Manager, Document Control - Quality Systems & Compliance
Core
Provide site leadership and governance for GMP document control, records management, learning management, and training compliance across a large sterile injectable pharmaceutical manufacturing operation.
Role type
Manager, Quality Systems & Compliance
Builds
Controlled GMP documents, training systems, and compliance processes for aseptic manufacturing
Domain
Pharmaceutical manufacturing (sterile injectables) + Quality Systems/Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (Quality Management Systems)
Required skills
GMP document lifecycle management, electronic document management systems (eDMS), learning management systems (LMS), training compliance governance, regulatory inspection readiness, cross-functional partnership, CAPA implementation, data integrity principles, version control, records retention and archival
Preferred skills
Sterile/aseptic manufacturing experience, biologics experience, ICH Q10 knowledge, Veeva/MasterControl/TrackWise/SuccessFactors proficiency, Lean/Six Sigma certification, instructional design
Technologies
eDMS, LMS, Veeva, MasterControl, TrackWise, SuccessFactors, ComplianceWire
Responsibilities
Lead and develop the Document Control and Training Compliance team; own procedures and governance for controlled documents and GMP records; oversee the complete lifecycle of SOPs, work instructions, and master batch records; lead the site training compliance program and maintain the LMS; serve as the primary Quality Systems point of contact for regulatory inspections and audits; develop and report KPIs for document lifecycle and training performance
Seniority
Manager, leadership & governance
