The work that we do today will impact the lives, of people we do not know, in a humanistic way.
Document Control Manager
Location
United States
Posted
59 days ago
Salary
0
Seniority
Senior
Job Description
Document Control Manager
Cristcot
• 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
Job 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
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