GMP QA Manager - External Manufacturing Lead

AMERICAN REGENT, INC.; Brea (CA); Vor Ort; USD 118.000 - 124.000; Vollzeit

Zusammenfassung

AMERICAN REGENT, INC. is seeking a Quality Assurance Manager, External Manufacturing to lead GMP activities with contract manufacturers and ensure conformance to quality systems.

You will act as the QA lead for assigned projects, supporting lifecycle management from development to release of drug products. The role emphasizes collaboration with CMOs, supplier change decisions, and regulatory readiness, including inspections.

Qualifikationen

• Bachelor’s Degree in Engineering or science discipline or related field required.
• Minimum 8 years’ experience in Pharmaceutical QA preferred, with preferences of External Quality Management and sterile injectables.
• Strong working knowledge of current Good Manufacturing Practices, FDA and ICH Q8/9/10/12 guidelines.
• Direct experience participating and supporting regulatory inspections and submissions preferred.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.

Aufgaben

• Provide day-to-day quality input and oversight for life cycle development and commercialization at external manufacturing partners.
• Establish Quality KPI scorecards for compliance and performance metrics with CMOs.
• Facilitate communication between CMOs and American Regent teams; ensure GMP compliance and regulatory requirements.
• Support regulatory inspections and submissions; oversee engineering, validation, and batch documentation.
• Perform risk assessments and drive remediation actions; travel domestically or internationally 5–10%.

Kenntnisse

Quality Assurance

Regulatory inspections

Communication skills

Project management

Ausbildung

Bachelor’s Degree in Engineering or science

Tools

Microsoft Office

Electronic Quality Systems

Jobbeschreibung

AMERICAN REGENT, INC. is seeking a Quality Assurance Manager, External Manufacturing to lead GMP activities with contract manufacturers and ensure conformance to quality systems.

You will act as the QA lead for assigned projects, supporting lifecycle management from development to release of drug products. The role emphasizes collaboration with CMOs, supplier change decisions, and regulatory readiness, including inspections.