QMS Specialist, Quality Assurance at Insmed in San Diego, CA

QMS Specialist, Quality Assurance Location: Research Development Lab - San Diego 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: The QMS Specialist, Quality Assurance will support QMS activities for the Insmed Gene Therapy site, including Training, Document Control, Deviations, CAPAs, Change Controls, Record Management, and Quality Metrics. What You'll Do: 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. In this role, you’ll have the opportunity to 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. You'll also: 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. Who You Are: You will have a minimum of a BS degree in Chemistry, Engineering,  Life Science or related discipline AND/OR  6 years of relevant Quality Assurance experience. You are or you have: 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. Where You’ll Work This role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs. #LI-EG1 #onsite Pay Range: $81,000.00-103,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: 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 Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application   or interview process, please contact us by email at TotalRewards@insmed.com  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or An alternative selection process by emailing Privacy@insmed.com. Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.