Manager, Document Control, QA Operations
Overview
Own the Document Control function within QA Operations at a state‑of‑the‑art cGMP facility in Columbus, enabling compliant management of controlled documents from authoring to lifecycle. Lead the eQMS program and drive cross‑functional collaboration across Manufacturing, QA, and QC. This role is unique for its combination of system ownership, regulatory readiness, and team mentorship in a fast‑moving biotech environment.
What You'll Do10
- 1Build and lead a high‑performing Document Control team with clear goals and accountability within the site strategy.
- 2Serve as the subject matter expert for the eQMS and Veeva Vault functionality, document authoring, revision workflows, and lifecycle processes.
- 3Evaluate, approve, and manage change controls in the eQMS ensuring regulatory alignment and operational impact analysis.
- 4Oversee issuance of controlled documents including batch records, labeling, forms, and logbooks to Operations and QC with accuracy and traceability.
- 5Author, review, and approve SOPs, work instructions, and related documents to maintain compliance.
- 6Oversee administration of eQMS stations in manufacturing areas to ensure current procedures and references are accessible and controlled.
- 7Develop, monitor, and report metrics for document change requests, controls, controlled copies, and periodic reviews to support timely evaluation.
- 8Collaborate with cross‑functional teams and SMEs to implement process improvements that enhance document control efficiency and compliance.
- 9Support maintenance, upgrades, and validation of the document management system and related procedures.
- 10Provide documentation support for regulatory inspections and internal audits to ensure readiness and compliance.
Requirements10
- 18+ years of experience in Document Control, Quality Systems, Quality Writing, or related GMP‑regulated roles
- 2Experience using an Electronic Quality Management System (eQMS), preferably Veeva Vault or similar
- 3Strong written communication, organization, and project management skills
- 4Experience leading, mentoring, or training employees
- 5Ability to manage competing priorities in a fast‑paced, deadline‑driven environment
- 6Proficiency with Microsoft Office applications including Outlook, Teams, Word, Excel, and PowerPoint
- 7Flexibility to work evenings, weekends, and holidays to support manufacturing schedules
- 8Preferred: Associate's or Bachelor's Degree
- 9Preferred: Proficiency with Project Management software (Smartsheet)
- 10Preferred: Formal training in technical writing or regulatory documentation
Salary Insight
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Location
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