Director, QC — Sterile Injectables & GMP Leadership

Kaye/Bassman International; Ohio; Presencial; USD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation assistance

Descripción de la vacante

Kaye/Bassman International is seeking a Director of Quality Control in central Ohio to lead two sterile injectable QC labs, guiding analytical, microbiology, sterility and environmental monitoring programs across operations and R&D.

The ideal candidate has 12+ years in pharma manufacturing with 8+ years in management, strong cGMP/GLP knowledge, and a proven track record in regulatory audits and CAPAs.

Formación

• BS in Life Sciences required at minimum; advanced degree preferred.
• 12+ years’ experience in the pharmaceutical manufacturing industry with at least 8 years in management.
• Experience with regulatory inspections/audits and cGMP/GLPs.

Responsabilidades

• Lead QC laboratories supporting sterile injectable manufacturing across two central Ohio sites.
• Oversee analytical, microbiology, sterility, bioburden and environmental monitoring programs.
• Manage and mentor laboratory personnel; drive CAPAs and deviations.
• Collaborate with Regulatory Affairs, Engineering and QA Compliance on new tech and processes.

Conocimientos

QC leadership

Sterility testing

Microbiology

Environmental monitoring

Regulatory audits

TrackWise

Lighthouse

People management

Educación

BS Life Sciences

MS/PhD preferred

Herramientas

TrackWise

Lighthouse

MS Office

Descripción del empleo

Kaye/Bassman International is seeking a Director of Quality Control in central Ohio to lead two sterile injectable QC labs, guiding analytical, microbiology, sterility and environmental monitoring programs across operations and R&D.

The ideal candidate has 12+ years in pharma manufacturing with 8+ years in management, strong cGMP/GLP knowledge, and a proven track record in regulatory audits and CAPAs.