Senior Quality Assurance Lead
3 weeks ago
We 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 implementation of quality policies and procedures that drive business success.
Key responsibilities include providing quality support and guidance for our CMC programs, overseeing GMP suppliers, conducting document reviews, managing 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.
This position requires a strong understanding of GMP regulations, quality management principles, and industry best practices. The ideal candidate will have a proven track record of driving quality excellence in a biotechnology or pharmaceutical setting and be able to demonstrate exceptional leadership and interpersonal skills.
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Quality Assurance Lead
3 weeks 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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Senior Quality Assurance Leader
2 days ago
Cambridge, Massachusetts, United States Amylyx Pharmaceuticals Inc Full timeAs a leader in the pharmaceutical industry, Amylyx Pharmaceuticals Inc is committed to delivering innovative solutions to address complex medical challenges. We are seeking a talented Senior Quality Assurance Leader to join our team and drive excellence in quality management.This role will be responsible for developing and implementing quality management...
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Quality Assurance Lead
3 weeks 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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Senior Quality Assurance Specialist
6 hours ago
Cambridge, Massachusetts, United States Philips Full timeAbout the PositionThis is an exciting opportunity to join our team as a Senior Quality Assurance Specialist and contribute to ensuring the highest level of quality in our products.Job DescriptionIn this role, you will be responsible for driving CAPA activities from issue identification to closure. You will project manage all CAPA activities, ensuring the...
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Quality Assurance Director Lead
3 weeks 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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Biologics Quality Assurance Lead
3 weeks 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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Lead Biologics Quality Assurance Director
3 weeks 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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Quality Assurance Professional
2 days ago
Cambridge, Massachusetts, United States Voyager Therapeutics Full timeJoin Our TeamVoyager Therapeutics is a rapidly growing biotech company looking for a Quality Assurance Specialist to join our team. This is an exciting opportunity to be part of a dynamic organization that is making a difference in the field of gene therapy.The successful candidate will have a strong background in quality assurance and compliance, with a...
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Director of Quality Assurance Biotechnology
3 weeks 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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Director of Biologics Quality Assurance
3 weeks 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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Validation and Quality Assurance Professional
2 weeks ago
Cambridge, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full timeAbout the RoleWe are looking for a talented Validation and Quality Assurance Professional to join our team at White Collar Technologies Inc. As a key member of our team, you will play a crucial role in ensuring the quality and compliance of our services.The salary for this position is $90,000 - $115,000 per year, depending on experience.Job DescriptionIn...
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Director of Quality Assurance
2 weeks ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeWelcome to Takeda Pharmaceutical, a world-leading biopharmaceutical company dedicated to improving lives through innovative medicines.About Us:We strive to create a diverse and inclusive work environment that fosters collaboration, creativity, and growth. Our commitment to equality and fairness has earned us recognition as an employer of choice.Job...
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Senior Engineering Quality Lead
7 hours ago
Cambridge, Massachusetts, United States Draper Labs Full timeAbout Draper Labs:At Draper, we tackle important national challenges with a focus on delivering innovative solutions. Our multidisciplinary teams of engineers and scientists work together to create successful and usable products.About the Job:This Senior System Quality Engineer position requires a highly skilled professional who can ensure that our products...
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Cambridge, Massachusetts, United States Philips Full timeAbout the RoleWe are seeking a seasoned Senior CAPA Engineer to join our team in Cambridge, MA. This is an exciting opportunity to drive quality improvement and contribute to the success of our organization.Job SummaryThe Senior CAPA Engineer will be responsible for leading CAPA activities from issue identification to closure. This includes project managing...
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Quality Assurance Manager
4 weeks 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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Senior Quality Assurance Engineer
2 weeks ago
Cambridge, Massachusetts, United States Verve Inc Full timeJob OverviewVerve Inc is seeking an experienced Senior QA Engineer to join our team in commercializing wearable solutions. As a key member of our organization, you will drive the development and execution of SQA strategies for both physical robot and cloud-based product lines.
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Senior Quality Assurance Engineer
2 weeks ago
Cambridge, Massachusetts, United States Verve Inc Full timeJob OverviewVerve Inc. is a cutting-edge technology company that specializes in wearable solutions for the modern workforce.We are currently seeking an experienced Senior QA Engineer to drive our commercialization and go-to-market strategy.This role will involve working closely with cross-functional teams to develop and execute SQA strategies for both...
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Manufacturing Quality Assurance Specialist
4 weeks 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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Microbiology Quality Assurance Specialist
2 weeks ago
Cambridge, Massachusetts, United States Synectics Inc Full timeJoin a leading pharmaceutical company as a Microbiology Quality Assurance Specialist and contribute to the development of life-saving vaccines!About Synectics Inc.Synectics Inc. is a renowned manufacturer of vaccines, dedicated to improving public health worldwide.Salary: $65,000 - $80,000 per yearAs a Microbiology Quality Assurance Specialist at Synectics...
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Senior Manager Quality Assurance Operations
2 weeks ago
Cambridge, Massachusetts, United States Marengo Therapeutics, Inc. Full timeAbout Marengo Therapeutics, Inc.Marengo Therapeutics is a pioneering biopharmaceutical company dedicated to developing innovative therapeutics that activate the right immune response to promote lifelong protection against cancer. Our team is passionate about making a meaningful difference in the lives of patients and their loved ones.Job OverviewWe are...