Related skills
quality assurance audits gxp capa vendor qualification📋 Description
- Lead and manage global Quality Agreements/QTAs.
- Develop, review, execute, and maintain agreements.
- Support internal and external audits; inspection readiness.
- Collaborate with CMC, Quality Control, Regulatory, Legal, CSPs.
- Identify risks; mitigate and ensure regulatory compliance.
- Participate in vendor qualification and internal audit planning.
🎯 Requirements
- Bachelor's degree in a scientific discipline; advanced degree a plus.
- 8+ years in biotech/pharma FDA-regulated QA.
- Hands-on experience drafting commercial Quality Agreements.
- Vendor qualification experience.
- Strong knowledge of global GxP regulations (FDA/EMA/ICH).
- Excellent communication and technical writing skills.
🎁 Benefits
- Market leading compensation
- 401K with employer match on first 3%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award
- Comprehensive health care premiums covered
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