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Senior Manager, GMP Operational Quality – Vendor Management
Vertex PharmaceuticalsGMP Operational Quality Senior Manager overseeing vendor management with focus on compliance and quality assurance in the pharmaceutical sector. Collaborating with cross-functional teams to resolve quality issues and ensure compliance.
About the role
Key responsibilities & impact- Collaborate with internally and external business partners to resolve complex quality issues
- Participates in cross-functional teams as an experienced Quality technical resource
- Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex
- Conducts quality investigations /deviations and reviews corrective action plans
- Ensures appropriate CAPA actions are identified and addressed
Requirements
What you’ll need- Bachelor's degree in a scientific or allied health field (or equivalent degree)
- Typically requires 6 years of experience, or the equivalent combination of education and experience
- In-depth knowledge of both the conceptual and practical application of cGMPs in a biologics pharmaceutical setting
- Strong experience managing complex projects with contract manufacturing organizations
- Ability to mentor and guide less experienced colleagues
- Strong experience in identifying, assessing and mitigating potential risks
Benefits
Comp & perks- Medical benefits
- Overtime pay
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality investigationscorrective action plansCAPA actionscGMPsproject managementrisk assessmentrisk mitigation
Soft Skills
collaborationmentoringguidance