Manager, C&Q Document Preparation (Drug Substance)

Responsibilities

• Lead a blended team of employees and contingent workers in the preparation and delivery of compliant C&Q documentation.
• Oversee the development of qualification protocols, reports, risk assessments, and traceability matrices.
• Partner with Engineering, Validation, Quality, and Manufacturing teams to ensure documentation aligns with project timelines and operational readiness.
• Execute C&Q documentation using established Center of Excellence (CoE) standards and templates to ensure consistency and compliance.
• Monitor documentation progress, identify potential risks, and drive timely resolution of issues.
• Maintain inspection-ready documentation to support regulatory inspections and internal audits.
• 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.
• 8–13 years of experience in GMP commissioning, qualification, validation, or technical operations within the pharmaceutical or biotechnology industry.
• Proven experience preparing or overseeing qualification documentation, including protocols, reports, and risk assessments.
• Strong understanding of risk-based qualification methodologies and lifecycle validation approaches.
• Experience working in regulated GMP manufacturing environments with a focus on inspection readiness.
• Demonstrated experience leading technical teams and managing multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience working within a Commissioning & Qualification Center of Excellence (CoE) model.
• Familiarity with Drug Substance manufacturing systems, process equipment, facilities, and utilities.
• Experience supporting global Engineering capital projects.
• Knowledge of 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 and make people’s lives easier, fuller, and longer. A biotechnology pioneer since 1980, Amgen discovers, develops, manufactures, and delivers innovative medicines to help millions of patients worldwide.