Manager, Document Control (QA Operations)
Core
Leads the Document Control team to manage, issue, and maintain controlled documents and records within a cGMP biomanufacturing environment using an eQMS.
Role type
Manager, Document Control (QA Operations)
Builds
Controlled document lifecycle processes, SOPs, batch records, and regulatory documentation for gene therapy manufacturing.
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Document control, Quality Systems, Quality Writing, eQMS (Veeva Vault), Project Management, Regulatory Compliance, Team Leadership, Process Improvement, Audit Support, Microsoft Office
Preferred skills
Technical Writing, Instructional Design, CDMO Operations, Regulatory Inspection Support, Project Management Software (Smartsheet)
Technologies
Veeva Vault, Microsoft Office, Smartsheet
Responsibilities
Lead and coach the Document Control team; manage document change controls and approvals; oversee issuance of controlled documents; author and review SOPs; support regulatory inspections and audits; develop and report KPIs for document effectiveness.
Seniority
Manager, hands-on leadership
