Cerevel Therapeutics is hiring a Remote Senior Manager Global Product Quality
\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, Parkinsonโs 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 peopleโs 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 Cerevelโs procedures and applicable health authorityโs 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 vendorsโ 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 Cerevelโs and/or vendorsโ 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 projectsโ 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. โข 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 โ QMS)\n* Support the development, implementation, and maintenance of Cerevelโs procedures and electronic Quality Management Systems\n* Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement โ from defining business need, project planning, development, deployment, and end user adoption โ 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* Bachelorโs 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 bachelorโs 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
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Cerevel Therapeutics is hiring a Remote Senior Manager Global Product Quality Early Stage R&D Ops
\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, Parkinsonโs 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 peopleโs 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 Cerevelโs procedures and applicable health authorityโs 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 vendorsโ 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 Cerevelโs and/or vendorsโ 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 projectsโ 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 โ QMS)\n* Support the development, implementation, and maintenance of Cerevelโs procedures and electronic Quality Management Systems\n* Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement โ from defining business need, project planning, development, deployment, and end user adoption โ 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* Bachelorโs 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 bachelorโs 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
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Lightspeed Commerce is hiring a Remote Senior Java Developer
\nHi there! Thanks for stopping by ๐\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 youโll 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 youโll 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 thatโll 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
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBerlin, Berlin, Germany
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Cerevel Therapeutics is hiring a Remote Senior Manager Global Product Quality
\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, Parkinsonโs 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 peopleโs 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 Cerevelโs procedures and applicable health authorityโs 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 vendorsโ 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 Cerevelโs and/or vendorsโ 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 projectsโ 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 โ QMS)\n* Support the development, implementation, and maintenance of Cerevelโs procedures and electronic Quality Management Systems\n* Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement โ from defining business need, project planning, development, deployment, and end user adoption โ 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* Bachelorโs 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 bachelorโs 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
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
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