Senior Document Control and Training Manager

Obsidian Therapeutics

Senior Document Control and Training Manager ensuring compliance in biopharma industry processes. Overseeing document management and training effectiveness for innovative cell and gene therapies.

Posted 5/15/2026full-timeBedford • Massachusetts • 🇺🇸 United StatesSenior💰 $129,000 - $167,500 per yearWebsite

About the role

Key responsibilities & impact

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
Own and manage the document control lifecycle for GxP documents
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)
Create and administer training of the new eDMS to all stakeholders
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

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
Retirement accounts
Paid time off
Wellness programs
Career growth opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

document controltraining program managementquality management systems (QMS)document management systems (DMS)learning management systems (LMS)SOP authoring and reviewregulatory compliancequality metrics trackingtraining effectiveness evaluationclinical-stage experience

Soft Skills

organizational skillsplanning skillscommunication skillscollaborationself-motivationflexibilitycuriosityresiliencetime managementinterpersonal skills