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Document Control Manager
<meta><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:14pt;white-space:pre-wrap;">Job Summary:</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:14pt;white-space:pre-wrap;">Primary Relationships:</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Within Cristcot: works across multiple departments, especially GxP departments where regulatory compliance is crucial to company success.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">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.</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:14pt;white-space:pre-wrap;">Primary Job Responsibilities:</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:14pt;white-space:pre-wrap;">The activities of the Document Control Manager will include</strong></b><span style="white-space:pre-wrap;">, but are not limited to:</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="white-space:pre-wrap;">Document Control & Systems Management</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Manage the lifecycle of controlled documents including SOPs, work instructions, policies, and templates.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Administer and optimize the electronic document management system (eDMS) on an ongoing basis, as needed.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ensure proper version control, archival, retrieval, and distribution of documents</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Establish and maintain document control procedures aligned with GxP requirements</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="white-space:pre-wrap;">Compliance & Quality</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ensure all documentation complies with FDA, EMA, ISO 13485, and ICH guidelines (e.g., 21 CFR Part 11, 210, 211, 820)</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Support internal and external audits, inspections, and regulatory submissions</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Maintain audit-ready documentation and ensure inspection readiness at all times</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Partner with QA to enforce document control policies and best practices</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="white-space:pre-wrap;">Process Improvement & Scaling</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Develop and implement scalable document control processes to support company growth</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Identify gaps and drive continuous improvement initiatives</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lead implementation or upgrades of document management systems</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="white-space:pre-wrap;">Cross-Functional Collaboration</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Work closely with Quality, Regulatory, Clinical, CMC, Medical Device, Commercial, and Manufacturing teams</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Train employees on document control procedures and systems</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Serve as the subject matter expert (SME) for document control across the organization</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="white-space:pre-wrap;">Team Leadership (if applicable)</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Hire, mentor, and manage document control staff as the organization grows</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Establish performance metrics and ensure high-quality output</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="font-size:14pt;white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:14pt;white-space:pre-wrap;">Skills and Qualifications:</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;"> </span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Bachelor’s degree in Life Sciences, Quality, or related field</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">5–8+ years of experience in document control within biotech, pharma, or regulated industry</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong knowledge of GxP requirements and regulatory standards (FDA, EMA, ISO 13485, Medical Device, and ICH)</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Experience with electronic document management systems (e.g., Compliance Quest, Veeva Vault, MasterControl, Documentum)</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Demonstrated ability to manage document lifecycles and ensure audit readiness</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Experience in early-stage or rapidly scaling biotech companies preferred</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Familiarity with clinical-stage and/or commercial manufacturing environments preferred</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Experience supporting regulatory submissions (IND, NDA) preferred</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lean / Six Sigma or process improvement experience preferred</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Exceptional attention to detail and organizational skills</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong understanding of compliance and regulatory expectations</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ability to work independently in a fast-paced, evolving environment</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Excellent communication and training skills</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Problem-solving mindset with a focus on continuous improvement</span></li></ul>