Director of Quality Oversight
4 days ago
We are a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. Our team is seeking an experienced Senior Director of Quality Assurance (GMP) to provide quality oversight of our clinical development programs and manufacturing.
Responsibilities:- Provide quality support and guidance for our CMC programs
- Plan, conduct or facilitate supplier qualification audits and site visits for GMP suppliers
- Provide quality oversight GMP suppliers
- Extensive document review and approval for: master batch records, executed batch documentation, analytical test methods, specifications, stability protocols and reports, release testing COAs and reports, etc.
- Review and support GMP investigations associated with lot-related deviations, change controls, CAPAs, OOS/OOT investigations
- Perform lot disposition
- Ensure that GMP quality documentation is securely archived and retrievable
- Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions
- Contribute to the development of our QMS as needed
- Ensure inspection readiness at our GMP suppliers
- Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests
- Continuous improvement of quality and compliance practices to ensure highest standards are maintained
$220,000 - $260,000 per year
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GMP Quality Oversight Leader
7 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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GMP Quality Oversight Specialist
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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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Director of Biologics Quality Assurance
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Quality Assurance Director Lead
6 days 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 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 Quality Assurance
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Director of Quality Assurance Biotechnology
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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
7 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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Lead Biologics Quality Assurance Director
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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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Director of Quality Excellence
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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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GMP Quality Director
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Director of Quality Operations for Biologics
4 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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Senior Quality Assurance Lead
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Senior Manager Quality Assurance Operations
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Strategic Human Resources Director
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Lab Operations Director
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Director of Quality Assurance Management
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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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Technical Director for Software Development
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Associate Director QA Operations Lead
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