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Vericel
Cambridge, MA, United States
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Qu
Job Source: VericelHillevax
Boston, MA, United States
Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of m
Job Source: HillevaxHilleVax, Inc.
Boston, MA, United States
HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 mil
Job Source: HilleVax, Inc.Ultragenyx Pharmaceutical Inc.
Bedford, MA, United States
???? **Privacy Notice** **Director, Quality Assurance (Warehouse Operations)** Bedford, MA / Ultragenyx UGT Project Vector QA / Full-time *Be a hero for our rare disease patients* At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve
Job Source: Ultragenyx Pharmaceutical Inc.Intellia Therapeutics
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determ
Job Source: Intellia TherapeuticsVertex Pharmaceuticals
Boston, MA, United States
Director, Apheresis Quality Operations (Hybrid) page is loaded Director, Apheresis Quality Operations (Hybrid) Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-21794 Job Description General/Position Summary The Director, Cell & Gene Quality, International will su
Job Source: Vertex PharmaceuticalsVertex Pharmaceuticals, Inc
Boston, MA, United States
Job Description General/Position Summary The Director, Cell & Gene Quality, International will support defining the strategy for the international expansion of Cell & Genetic programs. The role will establish the quality risk management plans, work closely with cross-functional QA, CMC, External manufacturing, Supply Chain and Commercial teams to e
Job Source: Vertex Pharmaceuticals, IncProfessional Staffing Group
Boston, MA, United States
Office Administrative Manager What's In It For You: - Competitive Pay - Great benefit packages - Generous Paid Time Off - Strong opportunity for professional and career growth - Good onboarding program - Join a collaborative and empowering team - Solid job security - Fun and friendly work environment About the Opportunity: - A well-kno
Job Source: Professional Staffing GroupCambridge, MA, United States
Quality Operations Director
Key Responsibilities:
Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.
Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.
Maintain and oversee a robust quality management system.
Collaborate effectively with cross-functional teams to ensure seamless product launches.
Proactively identify, assess, and mitigate quality risks.
Oversee the Quality Operations department, including 11 direct reports
Qualifications:
Bachelor's degree in a relevant field, with a minimum of 14 years of experience (10+ years in Quality, 8+ years managing quality personnel). Alternatively, a Master's degree with a minimum of 12 years of experience (10+ years in Quality, 8+ years managing quality personnel) is acceptable. Prior leadership experience is essential.
In-depth understanding of regulatory requirements for the biopharmaceutical and/or medical device industry.
Excellent written and verbal communication skills.
Demonstrated ability to lead and develop a high-performing team.
Preferred Qualifications:
Prior experience in the medical device or biotechnology industry (biologics)
Internal and external quality audit oversight
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Email Alert for Director of Quality Operations jobs in Cambridge, MA, United States
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