\nAbout Betterworks\n\nBetterworks provides enterprise software to easily manage strategic plans, collaborative goals (OKRs), and ongoing performance conversations.  Betterworks software helps high-performing companies get aligned, and execute more effectively. \n\nBetterworks' mission is to build solutions that help companies execute their strategic objectives through people engagement, performance enablement and decision analytics. We are working with some of the world’s leading brands like Walmart and Intuit to disrupt the business and talent management spaces with next-generation Strategic Execution and Performance Management solutions. \n\nWhat You’ll Be Doing\n\nAs a Senior Software Engineer at Betterworks, you will be responsible for developing an enterprise-class continuous performance management system. You will,\n\n\n* Build a complex talent management application that will drive decision-making at scale in large enterprises.\n\n* Implement an architecture that will scale as the product grows.\n\n* Build a complex application that will drive decision making at scale in large enterprises\n\n* Develop clean, efficient, and maintainable code using best practices\n\n* Collaborate with product managers, designers, qa and other stakeholders to translate requirements into technical specifications\n\n* Mentor and provide guidance to junior team members\n\n* Conduct code reviews and ensure adherence to coding standards\n\n* Troubleshoot and debug issues to ensure optimal performance and reliability\n\n* Stay updated on emerging technologies and trends in software development\n\n\n\n\nWhat’ll Help You Be Successful\n\n\n\n* Bachelor's or Master's degree in Computer Science, Engineering, or a related field.\n\n* 5+ years of experience in Software Development.\n\n* A strong full stack developer experience with Django , nodejs\n\n* Good understanding of Web Application and Backend development technologies\n\n* Strong understanding and working experience in REST APIs\n\n* Working experience with Postgres or similar relational database\n\n* Strong engineering practices - pair programming, test-driven development, jest, git-flow\n\n* Working experience of AWS lambdas is a plus\n\n* Integration experience is a plus\n\n* Solid understanding of software engineering principles, design patterns, and best practices\n\n* Excellent problem-solving and analytical skills\n\n* Ability to work independently and as part of a team in a fast-paced environment\n\n* Strong communication and collaboration skills\n\n* Experience with Scrum methodologies and remote teams is a plus\n\n\n\n\nWhat We All Do\n\n\n* All employees share the responsibility of being aware of information security risks and adhering to information security policies and procedures. \n\n* All employees are required to participate in information security awareness and training programs. \n\n* All employees have a responsibility to handle data in accordance with data classification and handling guidelines. Employees should be aware of the sensitivity of the data they interact with and follow appropriate security measures. \n\n* All employees have a responsibility of reporting information security incidents in accordance with information security policies and procedures. \n\n\n\n\nLife at Betterworks\n\nAt Betterworks, we prioritize our people. In that spirit, we’ve put together a great benefits program to support our employees’ health and wellness that includes the following:\n\n\n* Work closely with a cross functional team of highly motivated and intelligent folks with a unique range of startup and enterprise experience.\n\n* Balanced Work / Life with unlimited vacation.\n\n* Vibrant company culture with frequent team building events.\n\n* Competitive salary with stock options.\n\n* Company sponsored health and personal accident insurance benefits.\n\n* Remote first work culture that allows you to work from anywhere in India and travel to meet as a team when possible.\n\n* A one-time reimbursement for work from home office set up.\n\n* A monthly stipend for internet.\n\n\n\n\nAbout Betterworks\n\nBetterworks® aligns, develops and activates your workforce for business growth. Through our easy-to-use, integrated software solutions and expertise, we help organizations replace outdated annual review processes with powerful Continuous Performance Management® programs that help managers be better at the conversations, coaching and development necessary to inspire and motivate the entire workforce to meet today's goals and be ready for tomorrow's challenges. Our solution supports truly global workforces, and is used daily by workers from more than 100 countries with localization support in more than 20 languages.\n\nFollow Betterworks on Twitter or connect with us on LinkedIn\n\nWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to inclusive and diverse betterworks. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse, global betterworks Community. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer. \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Django, Senior, Engineer and Backend jobs that are similar:\n\n $50,000 — $100,000/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

\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior/Executive Director of Quality to join its team in Europe. \n\n\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\n\n\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a highly qualified and experienced professional to join our team as the Head of Quality. This position will provide both overall direction and hands-on operational execution in establishing, implementing, and maintaining a phase-appropriate and continuously evolving Quality Management System (QMS). The ideal candidate will have background in late clinical stage and first commercialization of products including GCP, GMP, GVP and other relevant GxP, with a pragmatic true fit-for-purpose approach.\nThe position will report to the Chief Operating Officer.\n\n\n\nRoles and Responsibilities:\n* Lead the development, implementation, and continuous improvement of a phase-appropriate Quality Management System (QMS), including policies, processes, and procedures.\n* Collaborate with internal functions to assure effective vendor selection, qualification, and oversight to ensure clinical trials and other outsourced GxP activities are conducted in accordance with all relevant laws, regulations, and guidelines.\n*   Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures.\n* Create, implement, and oversee audit plans for CROs, CDMOs and other GxP vendors. Assess and respond to audit outcomes.\n* Lead preparations for regulatory inspections and ensure ongoing inspection readiness.\n* Provide  GCP advice and audit for clinical studies to ensure they are conducted in accordance with FDA, EMA, ICH and other applicable requirements, guidelines and laws.\n* Identify any training requirements to meet the quality standards and ensure training is completed.\n* Maintain and expand regulatory knowledge, to the ICH Principles of GCP, GMP, General Data Privacy Regulation and International GxPs; provide industry leading compliance guidance and quality assurance consultation to internal and external stakeholders.\n* Manage all relevant external QA vendors e.g. quality auditors, consultants, etc.\n\n\n\nQualifications:\n* 10+ years of experience in QA roles with a mix of Biotechnology/Pharmaceutical and/or CMO/CRO companies.  At least part of the time should have been in a small to medium sized biotech or pharma company.\n* In-depth understanding and application of GxP principles, concepts, practices, and standards.\n* Demonstrated experience in establishing and managing quality systems in small to mid-sized companies.\n* Thorough understanding of GCP and GMP standards for late clinical and early commercialization stages; as well as of both US and EU requirements. \n* Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory - required. In-depth knowledge in international regulatory landscape - preferred.\n* Proven experience in building key metrics, reporting, and enhancing recruitment technology and systems to influence decision-making and provide compelling story telling.\n\n\n\nSkills:\n* Excellent oral, written and interpersonal communications skills to effectively interact, and exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.\n* Pragmatic and practical approach; understanding of “fit for purpose” approach. \n* Team player with positive attitude who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. Must be able to work under pressure, manage time, set priorities and meet deadlines.\n* Highly independent.  \n* Experience working in virtual and global setting.\n* Ability to take initiative, be accountable for individual and team results, motivate self and others to set and achieve very high-performance standards.\n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in Europe. \n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n* Occasional travel is expected.\n\n\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 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\nEurope

\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, Product Complaints & Quality Systems will be responsible for the design, development, implementation, and maintenance of the product quality complaints management system for R&D and commercial products in a manner that is compliant with regulatory requirements and business needs in terms of receiving, documenting, investigating, resolving, and responding to product quality complaints and other post-market feedback.\n\n\n\n\nThis role is also responsible for the oversight and monitoring of GMP quality systems and partnering with Global Quality team members and cross-functional partners to develop/enhance KPIs, enhance Veeva QMS Modules, ensure robust Veeva QMS records, and support inspection readiness. \n\n\n\nKey Responsibilities \n* Provide oversight of quality systems for R&D and Late Phase/Commercial GMP activities including Change Control, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints\n* Design, implement, and maintain product quality complaint handling (documentation, coordination, investigation, resolution, closeout) and investigation processes and procedures for R&D and commercial products in compliance with regulatory requirements (21 CFR 210, 211) and internal procedures\n* Partner with Global Drug Safety to ensure that complaints associated with an Adverse Event (AE) or Serious Adverse Event (SAE) are reported timely to GDS in accordance with internal procedures\n* Write/review internal/vendor Change Controls, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints and ensure they are properly documented in Veeva and inspection ready\n* Partner with internal stakeholders and vendors to drive on-time closure of complaint and QMS records  \n* Support validation, implementation, and maintenance activities for the Veeva QMS & Complaint Modules\n* Develop, implement, and maintain GMP Quality System and complaint metrics/KPIs to monitor performance and drive continuous improvement activities. Report metrics and trends to Senior Management for Management Review, QE & CAPA Board Meetings, internal audits, and other ad hoc meetings, as required. Escalate issues requiring immediate attention per procedure\n* Escalate critical complaints, quality events, trends to senior management timely per procedure\n* Gather complaint and QMS data to assist with Annual Product Reviews. Also support any potential stock recovery/recall, and/or field alert/field correction activities, if needed\n* Participate in the qualification, onboarding, and product training of call center for handling of commercial product quality complaints\n* Work with internal stakeholders to establish and maintain feedback systems and other post-market surveillance processes\n* Participate in internal/vendor audits and health authority inspections as needed\n* Support GMP quality systems by driving regulatory compliance in accordance with applicable regulations and business objectives\n* Establish and maintain SOPs, work instructions, forms, templates, and other documents associated with Quality Systems and Product Quality Complaints\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 industry in QA or QC role supporting GMP Activities for Investigational Medicinal Products and/or Marketed Products\n* Experience in the design, development, implementation, and maintenance of a product complaints management program for marketed products\n* Technical writing experience; writing SOPs, investigations, performing root cause analysis, and identifying CAPAs\n* Strong analytical problem solving and decision-making skills\n* Experience participating in Health Authority Inspections\n* Experience working in electronic quality management systems (Veeva or equivalent)\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* 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 up to 20% domestic travel, occasional international travel may also be expected\n\n\n\nDesired Qualifications\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* Ability to coordinate timelines with internal customers and vendors\n\n\n\nEducation\n* Bachelor’s degree in life science or engineering field\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)

\nABOUT US\nInvivyd is a biopharmaceutical company on a mission to protect humans from serious viral diseases. The company is developing antibodies to transcend the limits of naturally occurring immunity to provide superior protection from viral diseases, beginning with COVID-19.\n\nOur company was established to address the urgent needs of the coronavirus pandemic and other viral infectious diseases – treatment for today and durable prevention for tomorrow. Our team is motivated by a collective mission-driven sense of urgency that permeates Invivyd’s culture. We make decisions quickly, trust employees in their areas of expertise, and collaborate efficiently. As a result, Invivyd employees are both quick thinkers and motivated doers. \n\nTHE HEART OF INVIVYD: OUR EMPLOYEES\n\nInvivyd is a company comprised of motivated biopharmaceutical experts who are driven to make an impact on global health. Each employee sees working at Invivyd as a once-in-a-lifetime career opportunity to bring differentiated products to the world—for COVID-19, influenza and beyond. Our employees all work remotely and are based in over 25 states, with a critical mass in the greater Boston area and many employees in the northeast as well as California.\n\nJob Title: Director, Clinical Development Quality Assurance and Compliance\n\nPosition summary: \n\nThe primary responsibility of the Director of Clinical Development Quality Assurance and Compliance will be to develop and lead all quality assurance and compliance activities for the clinical development organization at Invivyd. The individual will be responsible for driving Clinical Quality initiatives to completion in conjunction with Invivyd’s  Regulatory and Clinical departments and external vendors.  This position will also be responsible for coordinating, controlling, and continuously improving the internal quality assurance processes, primarily related to clinical development and related activities and systems.  The Director will coordinate audits to support GCP and other regulated activities and lead strategy and activities in support of health authority inspections. The individual will ensure compliance of clinical trials and development activities to global regulatory standards including FDA, EMA, and other international regulatory agencies.  They will also be responsible for clinical inspection readiness activities for Invivyd’s development programs.\n\n\n* Build the Clinical Development Quality Assurance and Compliance function and infrastructure to support Invivyd pipeline and other compliance-related activities such as GDPR compliance\n\n* Develop a risk-based audit program to conduct effective audits of internal processes, investigator sites, and vendors that support development activities\n\n* Create, implement and maintain efficient, phase-appropriate and compliant GCP systems\n\n* Partner with stakeholders to develop GCP-focused SOPs, policies and procedures consistent with corporate objectives\n\n* Partner with other stakeholders within Adagio (i.e. CMC) to build cross-functional and corporate policies and procedures and integration of systems/activities, when appropriate\n\n* Assist the Clinical Development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management\n\n* Provide QA Support for Clinical Vendor/CRO oversight:\n\n\n* Represent Adagio QA on Sponsor/CRO/Site project calls and provide updates to Management\n\n* Provide QA support for critical quality issues, protocol deviations and investigations\n\n\n\n\n\n* Assist in the development and implementation of GCP training programs and conduct training sessions as required\n\n* Establish quality procedures and tools in support of audit and compliance activities\n\n* Collaborate with key stakeholders in development and implementation of internal and external GCP audit plans;\n\n* Proactively identify potential quality issues/discrepancies and work with Management to effectively resolve in a compliant and timely manner;\n\n* Research changes and updates to ICH, GCP regulations and assess impact on Adagio systems and practices;\n\n* Assist in the preparation and coordination of internal and external stakeholder meetings\n\n* Participate on cross-functional team meetings as QA Subject Matter Expert\n\n* Lead activities in support of health authority inspections\n\n* Review regulatory documents and check for consistency and compliance with relevant regulations, standards and best practices\n\n\n\n\nCompetencies:\n\n\n* Excellent written and oral communication skills, with the ability to communicate complex information in a virtual environment;\n\n* Ability to work in a team and independently\n\n* Strong organizational skills with the ability to effectively multi-task and prioritize;\n\n* Ability to flexibly adapt to changing business needs and meet timelines;\n\n* Ability to analyze & interpret analytical data;\n\n* Ability to determine impact of issues on subjects, study conduct, clinical program development and company needs based on stage of development and risk profile\n\n* Strong attention to detail and good problem-solving skills;\n\n\n* Resourceful, self-starter and team player with a strong results orientation.\n\n\n\n\n\n\n\n\nRequirements\n\n\n* A Bachelor's degree in a scientific discipline or biotechnology field;\n\n* A minimum of 8 years relevant GCP experience in pharma/biotech company, working within quality systems and regulated GCP/ICH environments;\n\n* Experience leading and facilitating inspection readiness activities and hosting FDA and other regulatory agency inspections;\n\n* Experience managing internal and external audits,\n\n* Strong understanding of GCPs, FDA, EU and ICH regulatory standards/guidance documents;\n\n* Extensive knowledge of risk-based quality systems approaches, with a focus on ICH E-6 R2 GCP principles;\n\n* Ideally will also have experience in facilitating/participating in remote audits and quality activities; able to travel to Clinical sites/vendors as required; Travel Requirement expected to be 25%.\n\n\n\n\nAt Invivyd we strive to create a welcoming and inclusive environment.   Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.\n\nInvivyd is proud to be an equal opportunity employer.\n\n\n\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 Design and Design jobs that are similar:\n\n $70,000 — $120,000/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\nWaltham, Massachusetts, United States