Quality Assurance
Interim Head of Quality
Lead quality for an autologous cell therapy site through BLA submission and pre-license inspection readiness. A six to nine month interim engagement while the permanent search runs.
A typical mandate
The company manufactures an autologous CAR-T therapy for a B-cell malignancy at its own facility. The BLA is in preparation and the previous head of quality has moved on. Leadership wants an experienced interim leader in the seat from the first week.
What the role owns
- Lead QA, QC and quality systems across clinical and process performance qualification manufacturing
- Own batch disposition and release decisions for patient lots
- Drive pre-license inspection readiness, including mock inspections and gap remediation
- Review the quality content of the BLA alongside CMC and regulatory
- Stabilize deviation, CAPA and change control performance
- Support recruitment of and handover to the permanent head of quality
What great candidates bring
- Degree in a scientific discipline; advanced degree preferred
- 15+ years in GMP quality, with senior leadership in cell or gene therapy
- Hands-on experience hosting FDA pre-license or pre-approval inspections
- Deep knowledge of 21 CFR Parts 210, 211, 600 and 1271, and aseptic processing
- Experience with chain of identity and chain of custody for autologous products
- Available to be on site four to five days a week
Why it matters
- Defined six to nine month engagement with possible extension
- Direct reporting line to the Chief Technical Officer
- Clear mandate and decision authority from the executive team
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