Manage the lifecycle of controlled documents including SOPs, work instructions, policies, and templates.
Administer and optimize the electronic document management system (eDMS) on an ongoing basis, as needed.
Ensure proper version control, archival, retrieval, and distribution of documents
Establish and maintain document control procedures aligned with GxP requirements
Ensure all documentation complies with FDA, EMA, ISO 13485, and ICH guidelines (e.g., 21 CFR Part 11, 210, 211, 820)
Support internal and external audits, inspections, and regulatory submissions
Maintain audit-ready documentation and ensure inspection readiness at all times
Partner with QA to enforce document control policies and best practices
Develop and implement scalable document control processes to support company growth
Identify gaps and drive continuous improvement initiatives
Lead implementation or upgrades of document management systems
Work closely with Quality, Regulatory, Clinical, CMC, Medical Device, Commercial, and Manufacturing teams
Train employees on document control procedures and systems
Serve as the subject matter expert (SME) for document control across the organization
Hire, mentor, and manage document control staff as the organization grows
Establish performance metrics and ensure high-quality output

Bachelor’s degree in Life Sciences, Quality, or related field
5–8+ years of experience in document control within biotech, pharma, or regulated industry
Strong knowledge of GxP requirements and regulatory standards (FDA, EMA, ISO 13485, Medical Device, and ICH)
Experience with electronic document management systems (e.g., Compliance Quest, Veeva Vault, MasterControl, Documentum)
Demonstrated ability to manage document lifecycles and ensure audit readiness
Experience in early-stage or rapidly scaling biotech companies preferred
Familiarity with clinical-stage and/or commercial manufacturing environments preferred
Experience supporting regulatory submissions (IND, NDA) preferred
Lean / Six Sigma or process improvement experience preferred
Exceptional attention to detail and organizational skills
Strong understanding of compliance and regulatory expectations
Ability to work independently in a fast-paced, evolving environment
Excellent communication and training skills
Problem-solving mindset with a focus on continuous improvement

Document Control Manager

Key skills