14h ago
Director, Vendor Quality Management
Cambridge, MA
full-timelead Hybridbiotech
๐ Tech Stack
๐ผ About This Role
You'll lead the implementation of a global, risk-based GxP vendor oversight program at a late-stage biopharmaceutical company. Your work will ensure scalability for commercial operations and align with industry best practices. This role offers the chance to build and mature a right-sized audit and monitoring program.
๐ฏ What You'll Do
- Lead implementation of global risk-based GxP vendor oversight program.
- Establish end-to-end vendor lifecycle management framework.
- Develop tiered vendor segmentation and risk methodology.
- Build and mature risk-based audit and monitoring program.
๐ Requirements
- 10-15 years in pharmaceutical/biotech industry.
- 5+ years overseeing Vendor Quality Management.
- Deep understanding of GxP and Quality System requirements (US and EU).
- Experience designing and scaling Quality Management Systems.
โจ Nice to Have
- Experience with digital quality systems like eQMS and Veeva Vault.
- Hands-on experience with Veeva Vault preferred.
- Highly proactive and capable of independently managing key initiatives.
๐จ Hiring Process
Estimated timeline: 3-5 weeks ยท AI estimate
- 1Recruiter Callยท 30 min
- 2Hiring Manager Interviewยท 60 min
- 3Panel Interviewยท 60 min
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