Executive Director, CMC Quality Assurance
Skills
- Deep knowledge of GMP, GLP and device-specific standards (21 CFR 210/211/820/4, ISO 13485, ISO 14971, ICH Q8/Q9/Q10).
- Experience leading QA in biotech, including combination product and autoinjector/device experience.
- Proven experience managing vendor/CDMO relationships and audits.
- Strong capability in event/CAPA management, batch disposition and supplier management.
- Experience supporting regulatory submissions and inspections; inspection readiness.
- Risk management (FMEA and other tools) and design quality oversight experience.
- Project management and cross-functional collaboration skills.
Responsibilities
- Develop and execute QA strategy across drug and device development and manufacturing.
- Build, hire and scale a cross-functional QA team (pharmaceutical and device quality specialists).
- Ensure global regulatory compliance (FDA, EMA, ISO) for combination products and support inspection readiness.
- Oversee event management (deviations, complaints) and CAPA processes.
- Lead supplier and contract manufacturer audits, qualification and ongoing performance monitoring.
- Provide QA oversight for process development, technology transfer, comparability and stability activities; approve key protocols and reports.
- Represent QA on governance forums and serve as primary product quality contact during inspections.
- Support regulatory submissions (IND, BLA, IDE, PMA) and lead QA review activities.
- Provide GLP support for nonclinical studies and perform GLP audits as needed.
- Drive continuous improvement initiatives and quality culture across the organization.
Education
- BS in life sciences, engineering, or related field required.
- MS preferred; advanced degree advantageous.
Benefits
- Competitive salary and potential equity participation
- Medical, dental and vision benefits (typical biotech benefits package)
- 401(k) or retirement savings plan
- Flexible/remote work arrangement
- Paid time off and professional development support
- Opportunity to shape QA function at an early, high-impact stage
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