Manager, Commissioning & Qualification (c&q) Document Preparation - Drug Substance
Amgen UK
United Kingdom
Gmp commissioning and qualification experience
Preparation of protocols and risk assessments
Leading blended teams of employees and contingent workers
This role leads a blended team responsible for preparing compliant, inspection-ready documentation that enables successful commissioning and qualification of engineering systems
Job Summary
This role leads a blended team responsible for preparing compliant, inspection-ready documentation that enables successful commissioning and qualification of engineering systems.
The position requires partnering with multiple cross-functional teams including Engineering, Validation, Quality, and Manufacturing to ensure documentation aligns with project timelines.
Candidates must have a strong understanding of risk-based qualification methodologies and data integrity expectations within a regulated pharmaceutical environment.
Matching Summary
This role leads a blended team responsible for preparing compliant, inspection-ready documentation that enables successful commissioning and qualification of engineering systems.
Skills & Requirements
Must-have
GMP commissioning and qualification experience
Preparation of protocols and risk assessments
Leading blended teams of employees and contingent workers
Knowledge of lifecycle validation approaches
Experience with traceability matrices and testing documentation
Nice-to-have
Strong project management and organizational skills
Ability to translate technical requirements into clear documentation
Collaboration across Engineering and Quality teams
Continuous improvement initiative leadership
Excellent written and verbal communication skills
Key Requirements
8-13 years of work experience in relevant field
Bachelor's or Master's degree required
Experience in GMP commissioning, qualification, or validation