Manager, C&Q Document Preparation (Finished Drug Product / Packaging)
Core
Lead the preparation and delivery of commissioning and qualification (C&Q) documentation to support Engineering project execution and GMP manufacturing, packaging, and facility systems.
Role type
Manager, C&Q Document Preparation
Builds
Inspection-ready documentation enabling successful commissioning, qualification, and operational readiness of Engineering systems and capital projects.
Domain
Pharmaceutical/Biotechnology manufacturing and GMP compliance
Required skills
GMP commissioning and qualification, team leadership (blended workforce), 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) experience, Finished Drug Product and packaging systems qualification, global Engineering capital projects, continuous improvement initiatives
Technologies
GMP documentation templates, risk assessment tools, traceability matrices
Responsibilities
Lead team in preparing C&Q documentation for Engineering projects; Manage blended team of employees and contingent resources; Oversee development of qualification protocols, reports, and risk assessments; Partner with Engineering, Validation, Quality, and Manufacturing teams; Monitor documentation progress and resolve issues; Support regulatory inspections and internal audits; Drive continuous improvement in C&Q practices.
Seniority
Manager, hands-on leadership
