QMS Specialist, Quality Assurance

Insmed•San Diego, CA

6d•Onsite

About The Position

The QMS Specialist, Quality Assurance manages Quality Assurance and regulatory compliance activities for Insmed Gene Therapy, supporting GMP compliance through QA oversight and monitoring and review of Quality System activities. Reporting to the Associate Director, Quality Assurance GMP, the role oversees QMS records and processes, including change controls, CAPAs, deviations, document change controls, effectiveness checks, periodic reviews, quality metrics, and related procedures. It also administers site Learning Management System training activities and supports document control, employee training, inspection readiness, and audits. The position is based in Insmed’s San Diego office and requires full-time, in-person attendance.

Requirements

Minimum of a BS degree in Chemistry, Engineering, Life Science, or a related discipline and/or 6 years of relevant Quality Assurance experience.
Direct experience with Change Control, Document Control, Deviations, CAPAs, and Effectiveness Checks in pharmaceutical or medical device products.
Understanding of cGMPs for pharmaceutical products.
Familiarity with pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
Experience working with an electronic document management system.
Experience reviewing procedural documents, change controls, manufacturing investigations, and laboratory investigations.
Ability to manage projects and variable workloads.
Strong organization and attention to detail, clarity, accuracy, and conciseness.
High proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
Proficiency in analyzing data trends in Excel or Minitab.
Full-time, in-person presence at the San Diego office.

Responsibilities

Oversee completion of QMS records, including document change controls, change controls, CAPAs, deviations, effectiveness checks, and periodic reviews.
Monitor the LMS and perform site training administration, including creating user accounts, monitoring and closing ServiceNow tickets, updating and assigning training curricula, and tracking upcoming training.
Provide input on QMS process design, compliance monitoring, continuous improvement, metrics, and day-to-day operations.
Support Change Control Committee materials and review and approve changes presented to the committee.
Facilitate feedback from Change Control Committee members.
Perform QA review of change controls, CAPAs, deviations, and effectiveness checks, ensuring completeness, accuracy, and compliance with applicable cGMP regulations.
Compile quality metrics for trending, follow up on closure of process improvements, and present and communicate trending reports in Quality forums.
Support training of Insmed Gene Therapy employees in QMS processes.
Upload and route Quality Records for approval in the Veeva Quality Documents electronic documentation system.
Perform QA Document Control review and approval of document updates.
Ensure QMS records meet process requirements, including use of appropriate document templates where applicable.
Review and update SOPs, policies, and standards to maintain compliance with GxP standards and applicable FDA, EMA, ICH, and other competent-authority requirements.
Monitor documents in the Periodic Review process and work with document owners to ensure timely review and updates.
Assist with inspection readiness and support internal reviews, FDA audits, and third-party consultant audits.

Benefits

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