Senior Document Control and Training Manager

Our Opportunity...

We are looking for a highly motivated Senior Document Control and Training Manager with a strong background in Document and Learning Management with both manual and digital systems. As a key contributor within the Quality Team, you’ll work collaboratively with all GxP stakeholders to manage and mature Obsidian’s Document Management System (DMS) and Learning Management System (LMS), helping to drive the development of our first clinical-stage autologous cell therapy program targeting solid tumors. 

You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.  

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

This is a Hybrid role based out of Bedford, MA.  

You Will...

Core responsibilities

• Ensure document control and training processes comply with cGxP, and applicable global regulations (FDA, EMA, ICH) 
• Author, review, and maintain SOPs governing document control and training processes 
• Support internal audits and regulatory inspections as necessary 
• Track, trend, and report key quality metrics at Management Review 
• Perform other project-related improvements to the QMS, DMS, or LMS as determined with management 
• Influence quality culture by promoting documentation excellence and compliance awareness across Obsidian 

Document Control:

• Own and manage the document control lifecycle for GxP documents (e.g., SOPs, policies, forms, templates, reports, etc.), currently a manual system. 
• Ensure timely authoring, review, approval, issuance, revision, archival, and obsolescence of controlled documents in accordance with regulatory requirements 
• Support inspection readiness by ensuring document accuracy, traceability, version control, and rapid retrieval 
• Lead the selection, validation, and implementation of an electronic Document Management System (eDMS) 
• Execute test scripts as part of the new system implementation and ongoing system updates 
• Create and administer training of the new eDMS to all stakeholders 

Training:

• Own and administer the GXP training program, including onboarding, role-based, and recurring training 
• Manage the Learning Management System (LMS), currently Compliance Wire, including curricula design, tracking, and reporting 
• Ensure training content aligns with procedures, job roles, and regulatory expectations 
• Monitor training compliance metrics and work with stakeholders to address overdue training 
• Partner with stakeholders to define training requirements for new SOPs, roles, or systems 
• Implement and manage training effectiveness evaluations on SOPs and courses 

You Bring...

Core Qualifications

• Bachelor's Degree in Life Science, Engineering, or related discipline with 8+ years of experience in a biopharma setting. 
• 6+ years of experience in Document Control, Training, and/or Quality Systems role in the biopharmaceutical industry 
• Hands-on experience with both manual DMS and electronic DMS, LMS, and/or QMS, preferably Veeva Quality Docs, Veeva Training, and/or ComplianceWire 
• Strong record-keeping and organizational skills, including an ability to manage multiple responsibilities in parallel. 
• Experience in clinical-stage environments 
• Excellent knowledge and understanding of applicable GXP regulations 
• Flexibility; a willingness and ability to adapt to changes in priorities in a fast-paced, dynamic, rapidly developing environment to advance our mission. 
• Excellent planning, coordination, and time management skills   
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.   
• Ability to build and maintain productive relationships with leaders, peers, and colleagues across the organization   
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes  
• Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.    
• Flexible - adapts to change in a fast-paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.