Manager, C&Q Document Preparation

Responsibilities

• Lead a blended team of employees and contingent workers in the preparation and delivery of C&Q documentation
• Oversee the development of qualification protocols, reports, risk assessments, and traceability matrices
• Ensure all documentation is compliant, inspection-ready, and aligned with established Center of Excellence (CoE) standards
• Partner with Engineering, Validation, Quality, and Manufacturing teams to support operational readiness and project timelines
• Monitor documentation progress, identify potential risks, and drive timely resolution of issues
• Support regulatory inspections and internal audits by maintaining high-quality documentation
• Provide leadership, coaching, and professional development to team members

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
• 5–9 years of experience in GMP commissioning, qualification, validation, or technical operations within the pharmaceutical or biotechnology industry
• Proven experience leading technical teams, including full-time employees and contingent resources
• Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
• Extensive experience preparing or overseeing qualification documentation such as protocols and risk assessments
• Deep knowledge of GMP documentation practices, data integrity, and inspection readiness

Preferred Qualifications

• Experience working within a Commissioning & Qualification Center of Excellence (CoE) model
• Familiarity with Finished Drug Product (FDP), packaging systems, facilities, and utilities qualification
• Experience supporting global Engineering capital projects in a regulated environment
• Exposure to continuous improvement initiatives focused on documentation quality and operational efficiency

About the Company

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases. A biotechnology pioneer since 1980, Amgen discovers, develops, and manufactures innovative medicines to help millions of patients worldwide.