QMS Specialist, Quality Assurance

Insmed Incorporated • San Diego, CA

4d • $81,000 - $103,000 • Onsite

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: Reporting to the Associate Director, Quality Assurance GMP, the QMS Specialist, Quality Assurance, will play a key role in managing QA and Regulatory Compliance activities for Insmed Gene Therapy. You will directly influence Insmed GMP compliance through QA oversight, monitoring and review of Quality System activities. In coordination with the Associate Director, Quality Assurance GMP, you will be responsible for Documentation Review as well as Monitoring, Review, and Approval of Quality Docs and QMS tasks including Change Controls, CAPAs, Deviations, Document Change Controls, Effectiveness Checks, Periodic Reviews, Quality System Metric Reviews, and related SOPs for these systems. Additional responsibilities will include Training Administration for site LMS curricula, such as creation of new user training accounts, monitoring and closure of ServiceNow tickets, updates to training curricula, assignment of training curricula to users, and tracking of trainings coming due.

Requirements

• You will have a minimum of a BS degree in Chemistry, Engineering, Life Science or related discipline as well as 2 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 of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
• Experience working with an electronic document management system.
• Experience at reviewing procedural documents, change controls, manufacturing investigations, and lab investigations.
• Demonstrate ability to manage projects and variable workloads.
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint and Outlook).
• Proficient in analyzing data trends in Excel or Minitab.

Responsibilities

• Oversee the completion of Quality Management System (QMS) records for Insmed Gene Therapy including Document Change Controls, Change Controls, CAPAs, Deviations, Effectiveness Checks, and Periodic Reviews.
• Monitor the Learning Management System (LMS) and perform site training administrator tasks, such as creation of new user training accounts, monitoring and closure of ServiceNow tickets, update to training curricula, assignment of training curricula to users, and tracking of trainings coming due.
• Provide input on QMS processes including process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations.
• Support facilitation of Change Control Committee materials and review and approval of changes presented to committee.
• Facilitate feedback from Change Control Committee Members
• Perform QA review of Change Controls, CAPA, Deviations, and Effectiveness Checks. Ensure completeness, accuracy, and compliance to all applicable cGMP regulations.
• Handle compilation of quality metrics for trending and follow up for the closure of process improvements. Present and communicate trending reports in respective Quality forums.
• Support training of Insmed Gene Therapy employees in QMS processes.
• Upload and route Quality Records for approval in Veeva Quality Documents electronic documentation system.
• Perform QA Document Control review and approval of document updates. Ensure QMS records comply with process requirements, including use of appropriate document templates, where applicable.
• Review and update SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
• Monitor documents for Periodic Review process and work with document owners to ensure timely document review and update, as applicable.
• Assist in inspection readiness activities and plays a key role during inspections/audits for QMS activities. Provide support during internal review, Audits, FDA Audits, and Third-party consultant Audits.

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