Senior Director of Quality Assurance
4 weeks ago
We are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.
As a Senior Director of Quality Assurance, you will 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
- Review 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
Qualifications:
- Bachelor's degree in a scientific field
- 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting
- Expertise in biologics is required
- In-depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO)
- Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
- Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously
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