Director of Quality Operations & Compliance

Confidential Careers; Florida; Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Confidential Careers in Florida seeks an experienced Quality Operations leader to drive cGMP compliance and regulatory readiness at an FDA-regulated manufacturing facility. The senior role oversees QA, QC, batch disposition, investigations, CAPA and inspections, partnering with Operations, Engineering, R&D and Supply Chain to ensure safe, high-quality OTC products and sustained regulatory readiness.

You will build a high-performing team, influence senior stakeholders, and lead continuous

Qualifikationen

• 12+ years of progressive quality leadership in FDA-regulated manufacturing.
• Experience leading Quality Operations at an OTC drug facility under cGMP.
• Proven success in FDA/Health Canada inspections and remediation.

Aufgaben

• Provide strategic and operational leadership for QA, QC, batch disposition, and finished-product release.
• Lead site preparation for regulatory inspections and responses to observations.
• Oversee CAPA, investigations, change control, and validation activities.
• Build a high-performing Quality organization and partner with cross-functional teams.

Kenntnisse

Quality leadership

Regulatory compliance

cGMP experience

Regulatory inspections

Quality systems

Cross-functional leadership

Data-driven decisions

Ausbildung

Bachelor's degree in Chemistry/Microbiology/Pharmacy/Engineering

Advanced technical or business degree preferred

Jobbeschreibung

Confidential Careers in Florida seeks an experienced Quality Operations leader to drive cGMP compliance and regulatory readiness at an FDA-regulated manufacturing facility. The senior role oversees QA, QC, batch disposition, investigations, CAPA and inspections, partnering with Operations, Engineering, R&D and Supply Chain to ensure safe, high-quality OTC products and sustained regulatory readiness.

You will build a high-performing team, influence senior stakeholders, and lead continuous