Director of Quality Control & Sterility Assurance

American Regent, Inc.; Columbus (OH); Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

American Regent Inc. in Columbus, OH, is seeking a Director of Quality Control to lead all laboratory activities supporting manufacturing and R&D.

This role oversees analytical, microbiology, and environmental monitoring across New Albany and Hilliard facilities, ensuring cGMP compliance and readiness for FDA and other audits. You will manage testing programs, supervise staff, develop SOPs, implement CAPAs, and collaborate with Regulatory Affairs, Engineering and Production to advance new

Qualifications

• Bachelor's in Life Sciences required; advanced degree preferred.
• Minimum 12 years in pharmaceutical manufacturing.
• Minimum 8 years of management experience.
• Experience with TrackWise for Deviations, CAPAs and CR process.
• Experience with environmental monitoring systems (Lighthouse).
• Strong knowledge of cGMP regulations and sterility/biotechnology QC.

Responsabilités

• Oversee day-to-day lab activities across sites (New Albany & Hilliard).
• Lead analytical, sterility, and microbiology testing programs.
• Approve validation and qualification SOPs.
• Mentor and supervise laboratory staff.
• Ensure compliance with cGMP/GLP and QA requirements.
• Coordinate with Regulatory Affairs and Production on new tech.

Connaissances

Leadership

Lab management

Microbiology

cGMP compliance

Regulatory readiness

Communication skills

Project management

Independent work

Formation

Bachelor's in Life Sciences

Advanced degree preferred

Outils

TrackWise

Lighthouse EM

Description du poste

American Regent Inc. in Columbus, OH, is seeking a Director of Quality Control to lead all laboratory activities supporting manufacturing and R&D.

This role oversees analytical, microbiology, and environmental monitoring across New Albany and Hilliard facilities, ensuring cGMP compliance and readiness for FDA and other audits. You will manage testing programs, supervise staff, develop SOPs, implement CAPAs, and collaborate with Regulatory Affairs, Engineering and Production to advance new