QA Director

We are seeking an experienced Quality professional to provide senior Quality leadership for an FDA-regulated Oral Solid Dose (OSD) pharmaceutical manufacturing operation. The role will oversee the Pharmaceutical Quality System, batch disposition and product release, regulatory compliance, inspection readiness, and Quality organization activities.

• Provide Quality leadership and oversight for OSD manufacturing operations.

• Oversee deviations, investigations, CAPA, change control, complaints, and Quality Risk Management.

• Support batch record review, batch disposition, and product release.

• Maintain FDA inspection readiness and support regulatory and customer audits.

• Provide oversight of process validation, cleaning validation, equipment qualification, and continued process verification.

• Drive Quality System improvements and reduction of investigation, CAPA, and change-control backlogs.

• Lead and develop the site Quality organization.

• Partner with site leadership, clients, and cross-functional teams on Quality and compliance initiatives.

• 12+ years of Pharmaceutical QA and GMP experience in FDA-regulated manufacturing.

• Significant Oral Solid Dose (OSD) manufacturing experience.

• 3 5+ years of Quality leadership experience at Senior Manager, Associate Director, Director, Site Quality Head, or equivalent level.

• Strong experience with batch record review, batch disposition, and product release.

• Experience with deviations, investigations, CAPA, change control, complaints, and Quality Systems.

• Experience supporting or leading FDA inspections and customer/regulatory audits.

• Strong knowledge of 21 CFR Parts 210 & 211, ICH Q9, ICH Q10, and EU GMP.

• Knowledge of Data Integrity and ALCOA+ principles.

• Experience with process validation, cleaning validation, and equipment qualification.

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Engineering, Life Sciences, or a related field.

• CDMO experience is preferred.