Manager, C&Q Document Preparation (Finished Drug Product / Packaging)
Core
Lead the preparation and delivery of commissioning and qualification (C&Q) documentation to support GMP manufacturing, packaging, and facility systems engineering projects.
Role type
Manager, C&Q Document Preparation
Builds
Inspection-ready documentation for commissioning, qualification, and operational readiness of engineering systems and capital projects.
Domain
Pharmaceutical/Biotechnology manufacturing and engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP commissioning and qualification practices, leading blended teams (employees and contingent), risk-based qualification methodologies, GMP documentation and data integrity, cross-functional collaboration, project management, standardized template usage
Preferred skills
Commissioning & Qualification Center of Excellence (CoE) model experience, Finished Drug Product and packaging systems qualification, global engineering capital projects, continuous improvement initiatives
Technologies
GMP documentation templates and processes
Responsibilities
Lead team in preparing C&Q documentation for engineering projects, manage planning and execution of deliverables across blended teams, oversee development of qualification protocols and reports, execute documentation preparation using CoE standards, partner with Engineering and Validation teams to support qualification execution, monitor documentation progress and resolve issues, maintain inspection-ready documentation, support regulatory inspections and audits, implement standardized C&Q practices, provide leadership and coaching to team members, contribute to continuous improvement initiatives
Seniority
Manager, hands-on leadership
