Quality Assurance Director Lead
19 hours ago
Jobot is a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. We are seeking an experienced Senior Director, Quality Assurance to provide quality oversight of our clinical development programs and manufacturing.
About the Role- Provide quality support and guidance for our CMC programs, ensuring seamless execution and compliance with regulatory requirements.
- Oversight GMP suppliers to guarantee high-quality materials and services.
- Ensure secure archival and retrieval of GMP quality documentation, maintaining transparency and accountability.
- Investigate potential quality impact of product complaints and temperature excursions, implementing corrective actions as needed.
- Ensure inspection readiness at our GMP suppliers, fostering strong relationships and open communication.
- Review and provide GMP quality feedback on regulatory application submissions and agency responses/information requests.
- Bachelor's degree in a scientific field or related discipline.
- 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting.
- Experience supporting early phase clinical through commercial manufacturing, including contract manufacturers.
This hybrid position requires 3 days on-site, with approximately 10-20% travel expected (domestic and international).
Compensation:$145,000 - $175,000 per year, offering a competitive salary package.
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Quality Assurance Lead
2 days ago
Cambridge, Massachusetts, United States Jobot Full timeWe are seeking a seasoned professional to fill the role of Senior Director of Quality Assurance (GMP) and lead our quality assurance efforts.The estimated salary for this position is approximately $180,000 per year, reflecting the industry standard and the specific requirements of this role.Your key responsibilities will include:Developing and implementing...
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Director of Biologics Quality Assurance
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeAbout the RoleWe are seeking a highly experienced Director of Biologics Quality Assurance to provide quality oversight of our clinical development programs and manufacturing.The ideal candidate will be an expert in biologics, specifically operational QA experience with monoclonal antibodies, and have a strong background partnering with external...
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Cambridge, Massachusetts, United States Jobot Full timeJob OverviewWe are a publicly traded biotechnology company developing innovative solutions for chronic dermatological diseases.Salary and Benefits$240,000 - $270,000 per year. Competitive salary, annual bonus, equity, ESPP, 401k program, medical/vision/dental benefits, and hybrid schedule.Job DescriptionWe seek a Senior Director of Quality Assurance (GMP) to...
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Quality Assurance Lead
2 days ago
Cambridge, Massachusetts, United States Third Rock Ventures Full timeKey ResponsibilitiesThe Quality Assurance Lead will be responsible for developing and implementing quality assurance procedures to ensure that all analytical methods and data meet regulatory requirements. This includes overseeing CDMOs for phase-appropriate analytical method development, qualification, validation, and transfer for in-process testing, drug...
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Director of Quality Assurance Management
7 days ago
Cambridge, Massachusetts, United States Marengo Therapeutics, Inc. Full timeAbout the RoleThis is an exciting opportunity for a seasoned quality professional to join our team as Director of Quality Assurance Management. As a key member of our operations team, you will be responsible for establishing and maintaining appropriate development phase GMP/GLP compliance. Your expertise in material/product disposition activities, testing...
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Director of Quality Assurance Biotechnology
19 hours ago
Cambridge, Massachusetts, United States Jobot Full timeJob SummaryWe are a publicly traded biotechnology company developing innovative treatments for chronic dermatological diseases. Our team is seeking a seasoned Senior Director of Quality Assurance (GMP) to provide expert guidance on quality oversight for our clinical development programs and manufacturing processes.The ideal candidate will have extensive...
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Senior Quality Assurance Lead
2 days ago
Cambridge, Massachusetts, United States Jobot Full timeAbout the RoleWe are seeking a highly experienced GMP Quality Director to join our team. As a key member of our quality leadership group, you will provide strategic direction and oversight for our quality assurance programs, ensuring compliance with regulatory requirements and industry standards. Your primary focus will be on supporting the development and...
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Cambridge, Massachusetts, United States Jobot Full timeAbout This RoleJob Summary:We are seeking a highly experienced Senior Director of Quality Assurance and Compliance to provide quality oversight of our clinical development programs and manufacturing. The ideal candidate will have expertise in biologics, specifically operational QA experience with monoclonal antibodies, and a strong background partnering with...
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Director of Biologics Quality Assurance
2 days ago
Cambridge, Massachusetts, United States Jobot Full timeJob Summary:We are seeking an experienced Senior Director of Quality Assurance (GMP) to provide quality oversight of our clinical development programs and manufacturing. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.About Us:We are a publicly traded biotechnology company...
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Biologics Quality Assurance Lead
2 days ago
Cambridge, Massachusetts, United States Third Rock Ventures Full timeRole Overview:We are seeking a highly experienced Senior Manager/Associate Director, Quality Control to lead our QC activities for antibody and fusion protein products across our pipeline.About the Job:In this role, you will develop strategies and execute QC activities for all pipeline programs. This includes in-process/release/stability testing,...
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GMP Quality Director
2 days ago
Cambridge, Massachusetts, United States Jobot Full timeJob ResponsibilitiesWe are looking for a highly skilled Senior Quality Assurance Lead to lead our quality assurance efforts. In this critical role, you will be responsible for developing and implementing quality policies and procedures that align with regulatory requirements and industry standards. Your expertise will ensure that our quality systems meet the...
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Quality Assurance Specialist
3 weeks ago
Cambridge, Massachusetts, United States The Steely Group Full timeJob OverviewThis role is an exciting opportunity for a seasoned Quality Assurance Specialist to join our client's team as a Compliance and Quality Systems Expert. Located in Cambridge, MA, this hybrid position offers the ideal blend of remote work and onsite collaboration.Key ResponsibilitiesSupport the development and implementation of quality systems and...
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Manufacturing Quality Assurance Specialist
1 week ago
Cambridge, Massachusetts, United States Insight Global Full timeJob OverviewInsight Global is a leading provider of innovative staffing solutions, and we are currently seeking a highly skilled Manufacturing Quality Assurance Specialist to join our team.About the RoleThis is an exciting opportunity for a seasoned professional with expertise in Corrective and Preventative Actions (CAPA) to analyze and advise...
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Quality Assurance GLP Leadership Position
3 weeks ago
Cambridge, Massachusetts, United States Bill and Melinda Gates Foundation Full timeJob Summary: We are seeking a highly skilled Quality Assurance GLP Lead to join our team at the Bill and Melinda Gates Foundation. The successful candidate will be responsible for managing GLP processes to ensure compliance with global laws, regulations, and applicable guidelines.
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Cambridge, Massachusetts, United States Korro Bio, Inc. Full timeJob SummaryKorro Bio, Inc. is seeking an experienced Senior Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in GMP regulations and a proven track record of ensuring compliance in a fast-paced biopharmaceutical environment.Key Responsibilities:Lead CMC quality assurance activities, ensuring compliance with FDA,...
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Quality Assurance Manager
7 days ago
Cambridge, Massachusetts, United States Disability Solutions Full timeJob OverviewWe are seeking a highly skilled and experienced Senior CAPA Manager to join our team at Disability Solutions. As a key member of our Patient Safety and Quality organization, you will be responsible for managing and leading cross-functional teams in driving CAPA activities from issue identification to closure.In this role, you will manage project...
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Quality Assurance Specialist
3 weeks ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeAt Vericel Corporation, a leading innovator in advanced therapies for sports medicine and severe burn care markets, we are seeking an experienced Senior Quality Control (QC) Analyst to join our Cambridge, MA location until our new state-of-the-art facility in Burlington, MA is operational.We offer a competitive salary range of $85,000 - $115,000 per year,...
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Cambridge, Massachusetts, United States Jobot Full timeJob Description:We are seeking a seasoned Senior Director of Quality Assurance (GMP) to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our operations.About Us:We are a leading biotechnology company dedicated to delivering innovative treatments for chronic...
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GMP Quality Oversight Leader
2 days ago
Cambridge, Massachusetts, United States Jobot Full timeAbout the Role:As a Senior Director of Quality Assurance (GMP), you will be responsible for providing quality oversight of our clinical development programs and manufacturing. This role requires a strong background in biologics and operational QA experience with monoclonal antibodies.Key Responsibilities:- Provide quality support and guidance for our CMC...
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Clinical Operations Director
3 weeks ago
Cambridge, Massachusetts, United States Lifelancer Full timeJob Description:We are seeking an experienced Clinical Operations Director to lead the management of late-stage clinical trials for our pharmaceutical company. This role will oversee the integration of project team activities, leveraging internal and development partner resources, expertise, and knowledge.About the Role:Provide strategic input and execution...