\nCompany Overview\n\n\nCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.  \n \nHeadquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.\n \nCerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.  Our patient-centricity guides our purpose, how we treat each other and what we work on every day.  The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.\n\n\nRole Summary\n\n\nThe Senior Manager, Global Product Quality will be responsible for both operational and compliance management of GMP and GLP QA activities at Cerevel to support the manufacture, packaging, testing, and supply of materials for use in early-phase toxicology studies and clinical trials. This individual will provide technical quality expertise and phase-appropriate compliance guidance to cross-functional teams internally and externally, in the development and implementation of cGMP compliant quality systems, to ensure product quality, data integrity, and most importantly, patient safety at Cerevel. In addition, this role will be responsible for overseeing a network of global vendors (e.g. CROs/CDMOs/CMOs), and will work closely with the GxP Quality Management functions to support the development and inspection readiness of Global Quality Management Systems, which may include but not limited to, GxP document management and training, deviation and CAPA management, change management, product quality complaints, risk management, vendor management, internal/external audits and inspection readiness, etc.\n\n\n\nKey Responsibilities \n*  Provide Quality oversight for GMP/GLP activities at Cerevel and its global vendors, which includes Contract Research Organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs)\n* Apply cGMP principles and requirements in a phase-appropriate manner to support the development and manufacture of clinical products while ensuring quality and compliance with Cerevel’s procedures and applicable health authority’s regulations\n* Review and approve GMP documentation, including Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors\n* Review and approve vendors’ executed batch records, analytical data, packaging and labeling records, to ensure timely disposition of drug substances, drug products and finished goods for use in clinical trials\n* Review, approve and track Cerevel’s and/or vendors’ product quality investigations, included but not limited to, deviations/nonconformances, CAPAs, out of trend (OOT), out of specification (OOS), product quality complaints, associated with manufacturing and analytical/stability testing\n* Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects’ timelines\n* Participate in and/or support Quality audits (internal and external) with the support of external quality consultants/auditors. Support vendor qualification activities, which may include auditing and approving of GMP/GLP vendors, providing recommendations, and following up on audit responses and resolution of CAPAs\n* Ensure Cerevel and vendors are in compliance with US and Global regulations, guidelines and industry standards in countries where Cerevel conducts GxP activities. Serve as a Person-in-Plant (PIP) at vendors, when needed. • Lead preparation for CDMO/CMO inspection readiness, when required\n* Review CMC regulatory filings and supporting documentation, as needed\n* Develop and oversee GPQ metrics/KPIs and report results to Senior Management\n* Serve as GPQ Representative in collaborating with Information Technologies and Quality Management in the selection, implementation, and maintenance of GxP electronic quality management systems and applications (e.g., Veeva Vault – QMS)\n* Support the development, implementation, and maintenance of Cerevel’s procedures and electronic Quality Management Systems\n* Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement – from defining business need, project planning, development, deployment, and end user adoption – and provide ongoing GMP functional oversight for all electronic quality management systems\n* Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization\n\n\n\nRequired Qualifications\n* 8+ years of relevant QA experience in pharmaceutical or biopharmaceutical industry in manufacturing, QA or QC role supporting GMP Activities for Investigational Medicinal Products and/or Commercial Products\n* In-depth knowledge of GMP/GLP QA principles and standards, as well as thorough understanding of FDA, EMA and ICH quality regulations necessary for day-to-day operations of clinical supply operations \n* Experience in working and managing CDMOs/CMOs to conduct GMP manufacture, testing, packaging/labeling, and/or distribution \n* Experience in authoring and implementing SOPs\n* Experience with Regulatory/Health Authority Inspections\n* Experience working in electronic quality management systems (Veeva or equivalent)\n* Experience with electronic Learning Management Systems \n* In depth knowledge of Validation Lifecycle requirements \n* Understanding of GAMP Validation Guidelines and Validation lifecycle requirements\n* Strong understanding of the Drug Development Process; ability to partner and build relationship with business function stakeholders and external vendors in order to enable high quality outcomes\n* Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs\n* Analytical problem solving and decision-making skills\n* Highly motivated, flexible and able to respond quickly to shifting priorities and meet deadlines, with excellent organizational skills and keen attention to details \n* Strong verbal and written communication skills to effectively communicate with business functions and vendors\n* Ability to travel as needed, may be up to 30% domestic travel, occasional international travel may also be expected\n\n\n\nDesired Qualifications\n* 2+ years of supplier quality experience managing GMP/GLP Vendors\n* Previous experience working in a R&D Quality role\n* Desire to work in a fast-pace, dynamic environment \n* Strong team player with a solutions-oriented and customer-service mind-set\n* Excellent interpersonal, problem solving with high degree of autonomy\n* Organized and efficient; delivers high-quality work\n* Experienced at leading teams and developing talent\n* Ability to coordinate timelines with internal customers and vendors\n\n\n\nEducation\n* Bachelor’s degree in life science (or equivalent) or engineering field relevant to pharmaceutical development; significantly more work experience in the relevant areas may be required for candidates without a bachelor’s degree\n\n\n\n\n\nCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $40,000 — $80,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)

\nCompany Overview\n\n\nCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.  \n \nHeadquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.\n \nCerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.  Our patient-centricity guides our purpose, how we treat each other and what we work on every day.  The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.\n\n\nRole Summary:\n\n\nThe Senior Manager, Global Product Quality will be responsible for both operational and compliance management of GMP and GLP QA activities at Cerevel to support the manufacture, packaging, testing, and supply of materials for use in toxicology studies, clinical trials, and commercial operations. This individual will provide technical quality expertise and phase-appropriate compliance guidance to cross-functional teams internally and externally, in the development and implementation of cGMP compliant quality systems, to ensure product quality, data integrity, and most importantly, patient safety at Cerevel.\n\n\nIn addition, this role will be responsible for overseeing a network of global vendors (e.g. CROs/CDMOs/CMOs), and will work closely with the GxP Quality Management functions to support the development and inspection readiness of Global Quality Management Systems, which may include but not limited to, GxP document management and training, deviation and CAPA management, change management, product quality complaints, risk management, vendor management, internal/external audits and inspection readiness, etc.\n\n\n\nKey Responsibilitites\n* Provide Quality oversight for GMP/GLP activities at Cerevel and its global vendors, which includes Contract Research Organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs)\n\n\n* Apply cGMP principles and requirements in a phase-appropriate manner to support the development and manufacture of clinical products and commercial products while ensuring quality and compliance with Cerevel’s procedures and applicable health authority’s regulations\n* Review and approve GMP documentation, including Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors\n* Review and approve vendors’ executed batch records, analytical data, packaging and labeling records, to ensure timely disposition of drug substances, drug products and finished goods for use in clinical trials and commercial operations\n* Review, approve and track Cerevel’s and/or vendors’ product quality investigations, included but not limited to, deviations/nonconformances, CAPAs, out of trend (OOT), out of specification (OOS), product quality complaints, associated with manufacturing and analytical/stability testing\n* Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects’ timelines\n* Participate in and/or support Quality audits (internal and external) with the support of external quality consultants/auditors. Responsible for vendor qualification activities, which may include auditing and approving of GMP/GLP vendors, providing recommendations, and following up on audit responses and resolution of CAPAs\n* Ensure Cerevel and vendors are in compliant with US and Global regulations, guidelines and industry standards in countries where Cerevel conducts GxP activities. Serve as a Person-in-Plant (PIP) at vendors, when needed\n* Lead preparation for CDMO/CMO inspection readiness when required\n* Review CMC regulatory filings and supporting documentation, as needed\n* Develop and oversee GPQ metrics/KPIs and report results to Senior Management\n* Serve as GPQ Representative in collaborating with Information Technologies and Quality Management in the selection, implementation, and maintenance of GxP electronic quality management systems and applications (e.g., Veeva Vault – QMS)\n* Support the development, implementation, and maintenance of Cerevel’s procedures and electronic Quality Management Systems\n* Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement – from defining business need, project planning, development, deployment, and end user adoption – and provide ongoing GMP functional oversight for all electronic quality management systems\n* Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization\n\n\n\nRequired Qualifications\n* 8+ years of relevant QA experience in pharmaceutical or biopharmaceutical industry in manufacturing, QA or QC role supporting GMP Activities for Investigational Medicinal Products and/or Commercial Products\n* In-depth knowledge of GMP/GLP QA principles and standards, as well as thorough understanding of FDA, EMA and ICH quality regulations necessary for day-to-day operations of clinical and/or commercial supply operations\n* Experience in working and managing CDMOs/CMOs to conduct GMP manufacture, testing, packaging/labeling, and/or distribution\n* Experience in authoring and implementing SOPs\n* Experience with Regulatory/Health Authority Inspections\n* Experience working in electronic quality management systems (Veeva or equivalent)\n* Experience with electronic Learning Management Systems\n* In depth knowledge of Validation Lifecycle requirements\n* Understanding of GAMP Validation Guidelines and Validation lifecycle requirements\n* Strong understanding of the Drug Development Process; ability to partner and build relationship with business function stakeholders and external vendors in order to enable high quality outcomes\n* Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs\n* Analytical problem solving and decision-making skills\n* Highly motivated, flexible and able to respond quickly to shifting priorities and meet deadlines, with excellent organizational skills and keen attention to details\n* Strong verbal and written communication skills to effectively communicate with business functions and vendors\n* Ability to travel as needed, may be up to 30% domestic travel, occasional international travel may also be expected\n\n\n\nDesired Qualifications \n* 2+ years of supplier quality experience managing GMP/GLP Vendors\n* Previous experience working in a clinical and/or commercial Quality role\n* Desire to work in a fast-pace, dynamic environment\n* Strong team player with a solutions-oriented and customer-service mind-set\n* Excellent interpersonal, problem solving with high degree of autonomy\n* Organized and efficient; delivers high-quality work\n* Experienced at leading teams and developing talent\n* Ability to coordinate timelines with internal customers and vendors\n\n\n\nEducation\n* Bachelor’s degree in life science (or equivalent) or engineering field relevant to pharmaceutical development; significantly more work experience in the relevant areas may be required for candidates without a bachelor’s degree\n\n\n\n\n\nCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $55,000 — $85,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)

\nHi there! Thanks for stopping by 👋\n\nLightspeed is looking for a talented and experienced Senior Java Developer. As a Backend developer, you will be supporting Lightspeed's Hospitality product group on the mission to expand our reach into new markets and countries while enhancing our advanced hospitality commerce platform. \n\n \n\nFor this role specifically, you will be joining our POS squad. This squad focuses on the core product and in building the fastest, easiest-to-learn and easiest-to-use POS in the world. . With research, product development, product design, engineering, and marketing all collaborating in one organization, we're able to quickly create meaningful features and services for millions of people around the world, resulting in joyful, long-lasting relationships for our customers. \n\n \n\nWe are looking for a thoughtful, well-rounded Backend engineer to join our team and help build tools that thousands of customers use every single day to manage their hospitality offerings. You will join a healthy and collaborative team, continuously improving our engineering practices, and delivering state-of-the-art technology, all while keeping it fun.\n\n \n\nAbove all, your work will change the way the world experiences hospitality!\n\n \n\nWhat you’ll be responsible for\n\n \n\n\n* Creating and extending the functionality of our products by contributing to our microservice-based platform\n\n* Developing clean, highly maintainable and well-tested code \n\n* Develop and evolve our overall backend architecture\n\n* Extending our continuous integration / continuous deployment environment\n\n* Working as part of a team (squad) to deliver product features and functionality\n\n* As part of a squad, you get to work with our Product Managers, Architects, and Principal developers\n\n* Extending your very own skills by learning from and growing with the team\n\n\n\n\n \n\nWhat you’ll be bringing to the team\n\n\n* Excellent communication skills \n\n* Excellent foundational knowledge of the Java programming language\n\n* Good knowledge of the Java ecosystem:\n\n\n\n* Spring, Spring Boot and the Spring Ecosystem\n\n* Maven (or Gradle)\n\n* Testing frameworks like Mockito, JUnit, Spock, Test containers, Cucumber \n\n* JPA, Hibernate or other ORM\n\n* Other common libraries and tooling like Lombok, Liquibase, Mapstruct, etc\n\n\n\n* Experience with both relational/SQL (eg. MySQL) and non-relational/NoSQL (eg. Elasticsearch, DynamoDB, Redis) databases\n\n* Experience writing automated unit and functional tests with one of the frameworks.\n\n* Solid foundation of knowledge in computer science\n\n* Able to analyse and debug production problems, incidents and performance issues.\n\n\n\n\n\n\n\n\nEven better if you have, but not necessary\n\n\n* Experience in multiple Java ecosystem frameworks.\n\n* Experience scaling Microservice architectures and implementing advanced patterns of distributed and fault-tolerant systems \n\n* Experience working in an Agile development environment\n\n* Experience with cloud environments like AWS or GCP and their products  \n\n* Experience with Kafka or other real-time messaging systems (eg. Pub/Sub)\n\n* Computer Sciences degree or equivalent\n\n* Experience with Docker & Kubernetes and running Java containers in the cloud\n\n* Experience in building and maintaining a CI/CD pipeline\n\n* Knowledge on Security topics (authentication and authorization patterns, OAuth2, PKI, etc)\n\n\n\n\n \n\nWho you are\n\n\n* You are a team player who likes to contribute to discussions and share your own experience.\n\n* You are self-motivated with the ability to function effectively in a team environment with minimum supervision.\n\n* You are always seeking improvement and progress.\n\n* You are eager to make decisions and not afraid of making mistakes.\n\n\n\n\n \n\nWhat is in for you\n\n \n\n\n* Lots of autonomy, flexible work culture and the possibility of remote work\n\n* Development of very high-traffic products, used at the global scale \n\n* Exposure to modern and proven technology\n\n* Opportunity to learn and expand your skill set\n\n* Tons of growth opportunities in technical or people management roles\n\n* Amazing benefits & perks, including equity for all Lightspeeders\n\n* Opportunity to join a fast-paced, high-growth company\n\n* Become a valued part of the diverse and inclusive Lightspeed culture\n\n\n\n\n \n\n ... and enjoy a range of benefits that’ll keep you happy, healthy and (not) hungry:\n\n \n\n\n* Lightspeed equity scheme (we are all owners)\n\n* Health & Wellness Credit- expense up to 400 EUR per year towards your gym membership, yoga classes, a new bike or whatever else you do for your health \n\n* Mental Health Support through the Modern Health App- whether it is meditation, coaching or counseling you need - each employee gets access to this platform \n\n* People Experience - Our PX benefit allows you to work from pretty much anywhere in the world for 60 days a year \n\n* LinkedIn Learning: At Lightspeed we believe in having a growth mindset, we provide free access to LinkedIn learning along with your career GPS to help you learn & grow\n\n* Subsidy to annual travel pass if you travel by public transport to the  Berlin office \n\n* Regular breakfast or lunches, drinks & snacks in our Berlin office\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Docker, Java, Cloud, Senior, Marketing, Engineer and Backend jobs that are similar:\n\n $60,000 — $110,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nBerlin, Berlin, Germany

\nCompany Overview\n\n\nCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.  \n \nHeadquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.\n \nCerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.  Our patient-centricity guides our purpose, how we treat each other and what we work on every day.  The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.\n\n\nRole Summary:\n\n\nThe Senior Manager, Global Product Quality will be responsible for both operational and compliance management of GMP and GLP QA activities at Cerevel to support the manufacture, packaging, testing, and supply of materials for use in late-phase and commercial operations. This individual will provide technical quality expertise and phase-appropriate compliance guidance to cross-functional teams internally and externally, in the development and implementation of cGMP compliant quality systems, to ensure product quality, data integrity, and most importantly, patient safety at Cerevel.\n\n\nIn addition, this role will be responsible for overseeing a network of global vendors (e.g. CROs/CDMOs/CMOs), and will work closely with the GxP Quality Management functions to support the development and inspection readiness of Global Quality Management Systems, which may include but not limited to, GxP document management and training, deviation and CAPA management, change management, product quality complaints, risk management, vendor management, internal/external audits and inspection readiness, etc.\n\n\n\nKey Responsibilities\n* Provide Quality oversight for GMP/GLP activities at Cerevel and its global vendors, which includes Contract Research Organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs) \n* Apply cGMP principles and requirements in a phase-appropriate manner to support the development and manufacture of commercial products while ensuring quality and compliance with Cerevel’s procedures and applicable health authority’s regulations\n* Review and approve GMP documentation, including Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors\n* Review and approve vendors’ executed batch records, analytical data, packaging and labeling records, to ensure timely disposition of drug substances, drug products and finished goods for use in commercial operations\n* Review, approve and track Cerevel’s and/or vendors’ product quality investigations, included but not limited to, deviations/nonconformances, CAPAs, out of trend (OOT), out of specification (OOS), product quality complaints, associated with manufacturing and analytical/stability testing\n* Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects’ timelines\n* Participate in and/or support Quality audits (internal and external) with the support of external quality consultants/auditors.  Support vendor qualification activities, which may include auditing and approving of GMP/GLP vendors, providing recommendations, and following up on audit responses and resolution of CAPAs\n* Ensure Cerevel and vendors are in compliance with US and Global regulations, guidelines and industry standards in countries where Cerevel conducts GxP activities. Serve as a Person-in-Plant (PIP) at vendors, when needed\n* Lead preparation for CDMO/CMO inspection readiness when required\n* Review CMC regulatory filings and supporting documentation, as needed\n* Develop and oversee GPQ metrics/KPIs and report results to Senior Management\n* Serve as GPQ Representative in collaborating with Information Technologies and Quality Management in the selection, implementation, and maintenance of GxP electronic quality management systems and applications (e.g., Veeva Vault – QMS)\n* Support the development, implementation, and maintenance of Cerevel’s procedures and electronic Quality Management Systems\n* Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement – from defining business need, project planning, development, deployment, and end user adoption – and provide ongoing GMP functional oversight for all electronic quality management systems\n* Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization\n\n\n\nRequired Qualifications\n* 8+ years of relevant QA experience in pharmaceutical or biopharmaceutical industry in manufacturing, QA or QC role supporting GMP Activities for Investigational Medicinal Products and/or Commercial Products\n* In-depth knowledge of GMP/GLP QA principles and standards, as well as thorough understanding of FDA, EMA and ICH quality regulations necessary for day-to-day operations of commercial supply operations\n* Experience in working and managing CDMOs/CMOs to conduct GMP manufacture, testing, packaging/labeling, and/or distribution\n* Experience in authoring and implementing SOPs\n* Experience with Regulatory/Health Authority Inspections\n* Experience working in electronic quality management systems (Veeva or equivalent)\n* Experience with electronic Learning Management Systems\n* In depth knowledge of Validation Lifecycle requirements\n* Understanding of GAMP Validation Guidelines and Validation lifecycle requirements\n* Strong understanding of the Drug Development Process; ability to partner and build relationship with business function stakeholders and external vendors in order to enable high quality outcomes\n* Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs.\n* Analytical problem solving and decision-making skills\n* Highly motivated, flexible and able to respond quickly to shifting priorities and meet deadlines, with excellent organizational skills and keen attention to details\n* Strong verbal and written communication skills to effectively communicate with business functions and vendors\n* Ability to travel as needed, may be up to 30% domestic travel, occasional international travel may also be expected\n\n\n\nDesired Qualifications\n* 2+ years of supplier quality experience managing GMP/GLP Vendors\n* Previous experience working in a commercial Quality role\n* Desire to work in a fast-pace, dynamic environment\n* Strong team player with a solutions-oriented and customer-service mind-set\n* Excellent interpersonal, problem solving with high degree of autonomy\n* Organized and efficient; delivers high-quality work\n* Experienced at leading teams and developing talent\n* Ability to coordinate timelines with internal customers and vendors\n\n\n\nEducation\n* Bachelor’s degree in life science (or equivalent) or engineering field relevant to pharmaceutical development; significantly more work experience in the relevant areas may be required for candidates without a bachelor’s degree\n\n\n\n\n\nCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $60,000 — $95,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)

\nAbout Karius\nKarius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body.  By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.\n\n\nPosition Summary\nThe Senior Clinical Data Scientist plays a critical role in driving the extraction, analysis and interpretation of clinical data to support evidence-based decision making and drive the development of innovative healthcare solutions. This position requires a strong background in data analysis, statistical modeling, and clinical research methodologies. The ideal candidate will have a passion for leveraging data to improve patient outcomes and contribute to the advancement of medical knowledge.\n\n\nWhy Should You Join Us?\nKarius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.\n \nReports to:    Vice President, Clinical Affairs\n \nLocation:  Redwood City, CA or Remote\n \nPrimary Responsibilities\n•   Responsible for the execution of statistical analyses of clinical and molecular data including initiating projects, overseeing execution, performing quality review, and leading cross-team communications.\n•   Collect, organize, and interpret statistical information from clinical databases, coded data, and other specified data sets.\n•   Uses appropriate statistical, visual, and narrative displays of data in a manner that is easily and appropriately interpreted by the target audience.\n•   Conduct statistical modeling to support both internal and external research projects.\n•   Collaborates on study protocols, statistical analysis or other project implementation plans with clinical development, scientific discovery, commercial, and product teams to address research questions and objectives.\n•   Identifies and advises on an appropriate statistical approach to a range of biomedical research questions.\n•   Carries out quality assurance and quality control procedures.\n•   Produces technical reports, peer-reviewed manuscripts, and presentations.\n•   Lead the integration of clinical trial data, electronic health record, insurance claims, disease, and patient data.\n\n\nWhat’s Fun About the Job?\nKarius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.\n \nTravel:      Travel required up to 5%.\n \nPhysical Requirements\nSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office. \n\n\nPosition Requirements\n•   5+ years experience, preferably at a diagnostic, biotech or pharmaceutical company analyzing large datasets, proficient in SQL, Python, R, or SAS.\n•   Graduate degree in statistics, biostatistics, epidemiology, informatics, or a related field. Additional coursework in programming, analytics, or related disciplines is strongly desired. PhD preferred.\n•   Solid proficiency in statistical methodology, particular for statistical measures related to diagnostic test accuracy and power and sample size calculations.\n•   Experience with data visualization, translating clinical data and information into a visual context to support publication and results reporting.\n•   Familiar with ICD-10 and CPT codes, AHRQ quality indicators, and other similar healthcare related tools and data, especially to support clinical impact, cost, and HCRU studies.\n•   Outstanding verbal, written, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally.\n\n\nPersonal Qualifications\n•   Excellent analytical skills to interpret complex clinical data, identify trends, and draw accurate conclusions.\n•   Attention to detail to ensure data quality and accuracy.\n•   Critical thinking to be able to identify and solve problems, develop innovative solutions and make informed decisions.\n•   Team player with the ability to collaborate effectively cross-functionally and work as part of a team.\n•   Strong communication skills with the ability to communicate complex data analysis results to both technical and non-technical stakeholders.\n•   Adaptability to new technologies and data sources, regulatory guidelines, and changing business needs.\n\n\nAt Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at [email protected] and we will accommodate qualified individuals with disabilities.\n\n\n\n\n\n\n$124,000 - $186,000 a year\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $60,000 — $110,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nUnited States