Document Control Manager

🕒 April 16

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Cristcot

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

💊 Pharmaceuticals

🔬 Science

🔥 Funding within the last year

💰 $10.5M Venture Round - Cristcot on 2025-06

Pharmaceuticals • Science

Cristcot is a pharmaceutical development and research company specializing in innovative drug formulations and unobtrusive drug-device combination technologies designed to improve patient adherence, reduce treatment burden, and integrate therapies into daily life. Founded in 2008 and headquartered in Austin, Texas, Cristcot provides clinical research design and execution, novel formulation and delivery engineering, specialized assay development, and regulatory strategy support; its lead investigational therapy has completed a pivotal Phase 3 study. The company focuses on solving overlooked barriers in disease management by creating intuitive, cost-effective solutions that enable more effective and confident care.

📋 Description

• 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