QMS Specialist, Quality Assurance

In coordination with the Associate Director, Quality Assurance GMP, primary areas of responsibility include Documentation Review and 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 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.

What You'll Do

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.