Senior Quality Manager
Listed on 2026-02-18
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Quality Assurance - QA/QC
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Healthcare
Data Scientist
A rapidly advancing biotechnology company is building out its GMP Quality leadership capability to support increasing external manufacturing activity and progression of biologic and advanced therapy programs toward commercialization.
This position will play a key role in quality oversight of contract manufacturing partners, batch documentation review, investigation management, and inspection preparedness, while collaborating cross‑functionally with CMC, regulatory, and technical operations teams.
The environment is fast‑paced, highly collaborative, and build‑stage, offering strong visibility and the opportunity to influence scalable quality systems and operational strategy.
Core Responsibilities
- Provide GMP quality oversight for manufacturing, testing, packaging, and distribution performed by external partners
- Review production and analytical documentation to support compliant batch disposition
- Lead or support investigations, root‑cause analysis, and corrective/preventive action activities
- Contribute to inspection readiness, audit participation, and regulatory response preparation
- Partner cross‑functionally to strengthen quality systems and operational processes
- Support continuous improvement and modernization of quality operations
Required Experience
- Approximately 10+ years of GMP Quality Assurance experience within biotechnology, biologics, or pharmaceutical environments
- Direct exposure to external manufacturing or supplier quality management
- Hands‑on involvement in batch review/disposition, deviations, OOS, or CAPA
- Participation in regulatory inspections or audit readiness activities
- Ability to operate effectively in dynamic or growth‑stage organizations
Preferred Background
- Experience with in virtual, emerging, or small biotech companies
- Exposure to cell therapy, gene therapy, or complex biologic modalities
- Comfort working cross‑functionally across CMC, regulatory, and technical operations
- Interest in data‑driven or digitally enabled quality environments
Technical Skills
Professional Skills
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