Forge Biologics
Manager, Document Control (QA Operations)
Columbus, Ohio · Senior
Sponsorship not specifiedDetected 1 day ago
AccessibilityProject ManagementExcelGMPLeadershipCommunicationMentoringWritingMicrosoft Office
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Entry-level history0
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Lottery odds40
Fits your clock70
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About the role
- The Manager, Document Control - QA Operations leads the Document Control team in the compliant and efficient management, issuance, and maintenance of controlled documents utilizing an Electronic Quality Management System.
- Supporting manufacturing, quality assurance, quality control, and related operations, this role ensures effective Document Control and Records Management processes while driving continuous improvement and cross-functional collaboration.
Responsibilities
- Provide leadership through effective communication, consistent coaching, reinforcing accountability, training, and development while removing roadblocks to support team execution.
- Serve as the subject matter expert for the document management system, including eQMS /Veeva Vault functionality, document authoring, revision workflows, and controlled document lifecycle processes.
- Evaluate, approve, and manage document change controls in the eQMS, assessing operational impact and ensuring alignment with internal procedures and applicable regulatory requirements.
- Oversee issuance of controlled documents, including batch records, labeling, forms, and logbooks, to Operations and Quality Control departments while ensuring accuracy, traceability, and compliance.
- Author, review, and approve controlled documentation, including Standard Operating Procedures (SOPs), Work Instructions, and related documents.
- Develop, monitor, and report metrics and key performance indicators for document change requests, document change controls, controlled copies, and periodic reviews to support timely stakeholder evaluation and document effectiveness.
- Collaborate with cross-functional teams, SMEs, and stakeholders to identify, lead, and implement process improvements that enhance document control efficiency, compliance, and procedural alignment.
- Support periodic maintenance, upgrades, and validation activities for the document management system, including related procedure updates.
- Provide documentation support for regulatory inspections and internal audits, ensuring documentation readiness, accessibility, and compliance.
Requirements
- 8+ years of experience in Document Control, Quality Systems, Quality Writing, or a related role within a GMP-regulated environment supporting manufacturing and/or laboratory operations.
- Experience managing cross-functional projects and stakeholder deliverables.
- Strong written communication, organization, and project management skills, with the ability to present technical documentation clearly to internal and external stakeholders.
- Proficiency with Microsoft Office applications, including Outlook, Teams, Word, Excel, and PowerPoint.
- Oversee administration of eQMS stations in manufacturing areas to ensure required procedures, forms, and reference documents are current, available, and controlled.
- Experience using an Electronic Quality Management System (eQMS), preferably Veeva Vault or a comparable document management platform.
- Previous experience leading, mentoring, or training employees and/or peers.
- Ability to manage competing priorities in a fast-paced, deadline-driven environment while maintaining accuracy, completeness, and compliance.
- Ability to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.
- Formal training in technical writing, instructional design, or regulatory documentation.
Nice to have
- Preferred Skills:
Skills
- Associate's or Bachelor's Degree.
- P roficiency with Project Management software (Smartsheet).
- Advanced skills in Microsoft Word formatting, styles, and templates. <span data-ccp-props="{"335559738":30,"335
- Your Future with Us:
- to enable access to life-changing gene therapies and help bring them from ideas into reality.
- At Forge, your growth matters.
Company info
- Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities.
- Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality.
- Here, you won't just watch innovation happen - you'll be part of it.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.