GMP Quality Director
3 days ago
We 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 highest standards and support our mission to deliver safe and effective treatments to patients.
Key responsibilities include providing quality oversight for our clinical development programs and manufacturing processes, managing GMP suppliers, conducting document reviews, investigating and evaluating potential quality impacts from product complaints and temperature excursions, and ensuring inspection readiness at our GMP suppliers. Additionally, you will provide quality review and feedback on regulatory application submissions and agency responses/information requests. Continuous improvement of quality and compliance practices will also be an essential part of this role.
Approximately 10-20% of the time will be spent traveling, both domestically and internationally. A Bachelor's degree in a scientific field and at least 10 years of experience in GMP quality or manufacturing in a biotechnology or pharmaceutical setting are required.
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GMP Quality Oversight Specialist
3 days ago
Cambridge, Massachusetts, United States Jobot Full timeJoin Jobot, a dynamic biotechnology company dedicated to developing cutting-edge treatments for chronic dermatological diseases. As a Senior Director, Quality Assurance, you will play a pivotal role in ensuring the highest quality standards across our clinical development programs and manufacturing processes.About the RoleFoster a culture of quality...
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GMP Quality Oversight Leader
3 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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Quality Assurance Director Lead
1 day ago
Cambridge, Massachusetts, United States Jobot Full timeJobot 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 RoleProvide quality support and guidance for our CMC programs, ensuring...
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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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Director of Biologics Quality Assurance
3 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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Director of Quality Assurance Management
1 week 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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Lead Biologics Quality Assurance Director
2 days ago
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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Cambridge, Massachusetts, United States Scholar Rock Full timeScholar Rock is a leading biopharmaceutical company dedicated to discovering, developing and delivering life-changing therapies for people with serious diseases. We are seeking a highly skilled Senior Specialist to join our Quality Assurance team.The successful candidate will be responsible for supporting the Quality Assurance department in planning,...
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Director of Quality Operations for Biologics
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeWe are a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases.Job OverviewThis role is part of our clinical development programs and manufacturing, ensuring the highest standards of quality oversight.Key ResponsibilitiesProvide quality support and guidance for CMC programsPlan, conduct or facilitate...
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Quality Assurance Lead
3 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 Quality Excellence
3 days ago
Cambridge, Massachusetts, United States Jobot Full timeWe are a publicly traded biotechnology company developing innovative biologics to address chronic dermatological diseases.The estimated salary for this position is approximately $175,000 per year, considering the industry standard and location. The role requires an expert in biologics, specifically operational QA experience with monoclonal antibodies, and a...
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Senior Quality Assurance Lead
3 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 timeJob OverviewThis Senior Director of Quality Assurance (GMP) role is available at a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.Compensation:$240,000 - $270,000 per yearResponsibilitiesProvide quality support and guidance for CMC programsPlan, conduct or facilitate supplier qualification audits and site...
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Senior QA Director for Clinical Development
2 days ago
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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Biologics Quality Assurance Lead
3 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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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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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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Quality Assurance Lead
3 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 Global Analytical Development
3 weeks ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeEmbark on a challenging career opportunity with Takeda Pharmaceutical as we seek an experienced Director of Global Analytical Development to lead our team in Cambridge, MA.Job OverviewWe are looking for a highly skilled and motivated individual to oversee the development of analytical control systems, ensuring compliance with regulatory requirements. The...
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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...