QA Manager: External Manufacturing & Compliance

American Regent; Brea (CA); Vor Ort; USD 118.000 - 124.000; Vollzeit

Zusammenfassung

American Regent is seeking a Quality Assurance Manager for External Manufacturing to lead GMP activities with CMOs and ensure compliance with cGMP, Quality Agreements, and regulatory standards. The role acts as the QA lead for assigned projects, coordinating lifecycle management from development to release of drug products.

Responsibilities include overseeing third-party manufacturing quality, driving risk reduction, supporting regulatory inspections, and maintaining submission readiness across

Qualifikationen

• Bachelor’s degree in Engineering or science discipline or related field required.
• Minimum 8 years’ experience in Pharmaceutical QA preferred, with emphasis on external quality management and sterile injectables.
• Strong working knowledge of cGMP, FDA and ICH Q8/9/10/12 guidelines.
• Direct experience with regulatory inspections and submissions is preferred.
• Ability to travel domestically or internationally 5–10%.

Aufgaben

• Provide day-to-day quality input and oversight for external manufacturing partners and lifecycle management.
• Support regulatory filings and on-site presence for inspections, validation, and batch releases.
• Review and approve quality records, change controls, investigations, and supplier documentation.
• Maintain inspection readiness and collaborate with ARI teams to drive risk-based improvements.
• Lead QA decisions for CMO/supplier-related tasks and ensure product safety and compliance.

Kenntnisse

Communication skills

Analytical thinking

Ausbildung

Bachelor’s degree in Engineering or science

Minimum 8 years’ experience in Pharmaceutical QA

Tools

Microsoft Office

Electronic Quality Systems

Jobbeschreibung

American Regent is seeking a Quality Assurance Manager for External Manufacturing to lead GMP activities with CMOs and ensure compliance with cGMP, Quality Agreements, and regulatory standards. The role acts as the QA lead for assigned projects, coordinating lifecycle management from development to release of drug products.

Responsibilities include overseeing third-party manufacturing quality, driving risk reduction, supporting regulatory inspections, and maintaining submission readiness across