GMP Quality Oversight Leader
3 days ago
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 programs
- Review and approve GMP quality documentation, including master batch records and executed batch documentation
- Ensure inspection readiness at our GMP suppliers
- Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions
Requirements:
- Bachelor's degree in a scientific field
- 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting
- Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
What We Offer:
- Estimated annual salary: $210,000
- Benefits package including medical, vision, and dental insurance
- Hybrid work arrangement with 3 days per week on-site
How to Apply:
Please submit your resume and cover letter for consideration.
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