Director, GMP Facility Launch & Operational Readiness
Hybrid · Raleigh, North Carolina, United States or Hanover, Maryland, United States
Job Summary
Directs enterprise-level site launch and readiness for GMP facilities, including facility completion, equipment installation/qualification (IQ/OQ/PQ), quality-system implementation, operational readiness and staffing, batch record finalization and release, customer validation support, mock runs and operational simulations, and commercial go-live execution. Requires a Bachelor’s degree in engineering or life sciences and 15+ years of leadership in regulated manufacturing; preferred advanced degree. Hybrid work arrangement with onsite collaboration, and potential 10-month onsite contract in Hanover, MD; strong emphasis on cross-functional leadership, regulatory readiness, and program management.
Required Qualifications
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Manufacturing, or related discipline
- 15+ years of leadership experience in pharmaceutical, biologics, medical device, sterilization, or highly regulated manufacturing environments
- Demonstrated success leading GMP manufacturing facility start-ups or major facility build-outs/operational launches
- Experience with cross-functional readiness programs
- Strong working knowledge of IQ/OQ/PQ execution
- Experience with GMP manufacturing systems and validation strategy
- Batch record execution
- Operational readiness planning
- Regulatory inspection readiness
- Ability to lead highly cross-functional teams in deadline-driven environments
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