Position Overview
Theย Manager,ย Document Controlย will support the head of Quality Systemsย toย defineย andย implement the corporate requirements for theย regulatedย Document Control Program.ย This role serves asย a critical member of the Quality Assurance team, responsible for the administration, maintenance, and continuous improvementย ofย theย Document and Records management process within the electronic Quality Management Systemย (eQMS). This role ensures that all controlled documentsย and electronic recordsย comply withย applicable regulations and internal standards, including, but not limited toย 21 CFR Parts 11,ย and Partsย 210/211. The Document Controller serves as both a subject matter expert and a hands-on practitioner, owning end-to-end document lifecycle managementย activitiesย whileย alsoย training and mentoring colleagues on system use andย internal requirements.ย
Responsibilities
- Author, own, andย maintainย SOPs, work instructions, and associated forms that govern the Document Control process, including document creation, formatting, review/approval, and archival.ย
- Ensure Document Control SOPs are aligned with applicable regulatory frameworks (21 CFR Part 11, EU Annex 11, ICH Q10) and reflect current system capabilities.ย
- Support internal SMEs as they author, format, andย finalizeย controlled documents.ย
- Ensureย all controlled documents are correctlyย formatted, numbered, version-controlled, and routed through the validatedย eQMS.ย
- Ensure thatย document metadata, classification, retention schedules, and archivalย areย establishedย inย compliance with regulatory requirements and company policies.ย
- Facilitateย periodic document review and support document owners throughย new,ย revision,ย and/orย obsolescenceย workflows.ย
- Design, build, andย maintainย controlled document templates for use across departments, ensuring visual consistency and complianceย toย internal procedures.ย
- Collaborate in the developmentย and delivery ofย engaging training materials (quick reference guides, job aids, video tutorials, classroom sessions) onย document managementย workflows including document creation, review, approval, and electronic signature processes.ย
ย Qualifications
- A minimum of 8ย years of experience in Document Control within a regulated biotechnology, pharmaceutical, or medical device environment, or equivalent.ย
- Aย minimum of anย Associate'sย Degree.ย ย
Knowledge and Skills
- Advancedย expertiseย with Office 365 (MS Word especially) and Adobe file types.ย
- Working knowledge of cGMP and current industry practices and standards forย management ofย regulated documents and records.ย
- Previousย experienceย setting up,ย implementingย and/orย working inย validatedย eQMSย systemsย (e.g.ย TrackWise,ย MasterControl, Veeva, Dot Compliance,ย ZenQMS, etc).ย