Associate Director, Quality Systems Document Control

Insmed Incorporated

3d • Hybrid

About The Position

Reporting to the Senior Director, Global Quality Assurance, the Associate Director, Quality Systems Document Control leads the document control function within the Quality Management System (QMS), ensuring documentation supporting GxP operations meets global regulatory requirements, internal quality standards, and lifecycle management expectations. You will provide leadership and operational oversight of document lifecycle management within the electronic QMS, ensuring processes are controlled, efficient, and inspection ready. You will support the execution of document management strategies by strengthening enterprise-level governance, advancing digital documentation capabilities, and implementing scalable processes that support business growth and operational needs. Partnering with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, and other cross-functional stakeholders, you will ensure documentation practices enable compliant operations and consistent quality standards.

Requirements

• Minimum BS degree in Chemistry, Life Science, or related discipline required
• 10 years of experience in Quality Systems and/or Document Control within regulated industries (Pharmaceutical, Biotechnology, Medical Device).
• Demonstrated experience supervising and leading document control operations.
• Direct experience with Document Control management in pharmaceutical or medical device products.
• Experience with enterprise electronic document management system (eDMS) implementation and governance.
• Full understanding of cGMPs for pharmaceutical products.
• Familiarity with other GxPs (GCP, GVP, GDP, GLP).
• Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
• Experience reviewing and approving procedural documents.
• Core competencies in enterprise-level strategic thinking, executive presence and stakeholder influence, strong analytical and risk-based decision-making capabilities.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and/or ISO 14971
• Demonstrate ability to manage projects and variable workloads.

Nice To Haves

• Veeva Vault Quality experience preferred

Responsibilities

• Define, supervise and execute global document control strategy aligned with leadership and corporate objectives.
• Drive harmonization of documentation processes across business units and regions.
• Lead and develop global Document Control initiatives.
• Identify and implement process improvement projects to drive Quality Management Systems success.
• Oversee processes within the QMS Document Control System, including process design, monitoring for compliance, and day-to-day operations.
• Manage and administer the Quality Document Control System.
• Manage and administer the on-site Document Archive Room.
• Maintain all activities supporting Document Change Control process, including controlled document lifecycle, change requests, classification, and retention procedures.
• Monitor, review, and approve Quality Documents.
• Review all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods, specifications, and technical documents.
• Support inspection readiness activities as subject matter expert.
• Provide support during internal audits, Health Authority audits, and third-party consultant audits.
• Conduct training of QA and stakeholders in QMS Document Control processes.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees