Senior / Document Control Manager

About Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

Job Summary:

We are seeking a highly organized and detail-oriented Document Control Manager to lead and manage our document control processes in a fast-growing biotech environment. The ideal candidate will bring deep experience in document control systems, including eQMS, regulatory compliance (GxP), and process improvement, along with the ability to build scalable infrastructure in a dynamic, early-stage company.

Primary Relationships:

• Within Cristcot: works across multiple departments, especially GxP departments where regulatory compliance is crucial to company success.
• Outside Cristcot: manages eQMS vendor, including changes to the system, document management and migration of CDMO documents, and manages the Cristcot review of CDMO documents.

Primary Job Responsibilities:

The Document Control Manager role is critical to ensuring that all GxP documentation is accurate, compliant, written to company brand standards, and audit-ready as we advance our programs toward clinical development and commercialization.

The activities of the Document Control Manager will include , but are not limited to:

Document Control & Systems Management

• 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

Compliance & Quality

• 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

Process Improvement & Scaling

• 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

Cross-Functional Collaboration

• 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

Team Leadership

• Hire, mentor, and manage document control staff as the organization grows
• Establish performance metrics and ensure high-quality output

Skills and Qualifications:

• 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
• Ability to travel up to 5%