Document Control Manager
Cristcot
full-time
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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
Requirements
- 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
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
document controlversion controlaudit readinessprocess improvementregulatory submissionsGxP requirementscompliancedocument lifecycle managementtrainingperformance metrics
Soft Skills
attention to detailorganizational skillscommunication skillsproblem-solvingindependenceleadershipmentoringcollaborationcontinuous improvementadaptability