Quality Operations Lead

I am currently partnered with a growing clinical-stage pharmaceutical company that is seeking a hands‑on Quality Operations Lead to support the build‑out and launch of a new manufacturing facility in Southwest Florida.

This is a high‑impact, on‑site role focused on establishing phase‑appropriate quality systems and supporting the transition from outsourced CDMO operations to in‑house manufacturing.

This position will report directly to senior Quality leadership and will play a foundational role in building and operationalizing the site’s GMP quality framework.

• Develop and implement phase‑appropriate GMP quality systems for investigational manufacturing
• Author and implement SOPs, policies, and procedural controls
• Support facility start‑up readiness and GMP compliance infrastructure
• Own document control, change control, deviation, and CAPA processes
• Support drug substance (API) manufacturing oversight
• Interface with external CDMOs during manufacturing transition
• Collaborate cross‑functionally with Facilities, Project Management, and Manufacturing
• Provide QA oversight with working knowledge of QC processes
• Support inspection readiness activities

• 5+ years of Quality experience in GMP‑regulated pharmaceutical environments
• Strong experience in API (small molecule preferred)
• Experience supporting facility start‑up, tech transfer, or early‑phase manufacturing
• Demonstrated experience authoring SOPs and building quality systems
• Working knowledge of QC processes (analytical methods, investigations, stability)
• Experience with electronic QMS/EDMS systems
• Ability to operate independently in a lean, build‑stage environment
• Radiopharmaceutical experience is a plus, not required