Director of Quality Control & Compliance (Multi-Site)

American Regent; Columbus (OH); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

American Regent in Columbus, Ohio seeks a Director of Quality Control to lead all laboratory activities supporting manufacturing and R&D, including analytical, microbiology and environmental monitoring across the New Albany and Hilliard facilities.

This role requires strategic oversight, hands-on management of CAPAs and deviations, and collaboration with Production, Regulatory Affairs and QA Compliance to implement new testing technologies and ensure strict cGMP and safety standards.

Qualifications

• Bachelors in Life Sciences at minimum; advanced degree preferred.
• Minimum 12 years of experience in pharmaceutical manufacturing.
• Minimum 8 years of management experience.
• Experience with TrackWise for Deviations, CAPAs and CR processes.
• Experience with environmental monitoring systems (Lighthouse) and method development in microbiology/analytical.

Responsabilités

• Lead day-to-day laboratory activities in support of manufacturing and R&D across multiple Ohio sites.
• Oversee analytical, microbiology, and environmental monitoring testing.
• Write, review, and approve validation and qualification SOPs; drive CAPA processes.
• Ensure cGMP/GLP compliance and support regulatory filings and audits.
• Hire, train, and manage laboratory personnel; provide coaching and mentoring.
• Collaborate with Production, Regulatory Affairs, Engineering, and QA Compliance on technology and process improvements.

Connaissances

TrackWise

Environmental Monitoring

Method Development

cGMP Compliance

MS Office

Leadership

Regulatory Compliance

Formation

Bachelor's in Life Sciences

Advanced Degree preferred

Outils

Lighthouse Environmental Monitoring

Description du poste

American Regent in Columbus, Ohio seeks a Director of Quality Control to lead all laboratory activities supporting manufacturing and R&D, including analytical, microbiology and environmental monitoring across the New Albany and Hilliard facilities.

This role requires strategic oversight, hands-on management of CAPAs and deviations, and collaboration with Production, Regulatory Affairs and QA Compliance to implement new testing technologies and ensure strict cGMP and safety standards.