Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

 

	Consistently Ranked Science’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

 

Reporting to the Director, Quality Assurance EMEA, the QA Manager training and QMS will play a key role in managing QA and Regulatory Compliance activities for Insmed. This role directly influences Insmed GMP / GDP compliance through QA oversight, monitoring and review of Quality System activities. Primary areas of responsibility include Documentation Review and Approval, Monitoring, Review, and Approval of QMS tasks including Change Controls, CAPAs, Deviations, Effectiveness Checks, Training, Periodic Reviews, Quality System Metric Reviews, and related SOPs for these systems. Additional responsibilities include Training, development and maintenance of training curricula, Trending, Monitoring, and Approvals.

Responsibilities :

• Primary responsibilities include overseeing completion and reviewing of Quality Management System (QMS) records for Insmed including Document Change Controls, Change Controls, CAPAs, (external) Deviations, Effectiveness Checks, Training, and Periodic Reviews.
• Provides input on QMS processes includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations. 
• Responsible for preparation of the Quality Management Review
• Supports facilitation of Change Control Committee materials and review and approval of changes presented to committee.
• Facilitates feedback from Change Control Committee Members.
• Coaches and guides QMS action owners to ensure effective record initiation, review, approval, implementation, and closure per applicable procedures and regulations.  Collaboratively works with cross-functional departments to support QMS activities.
• Performs QA review of (Document) Change Controls, CAPA, Deviations, and Effectiveness Checks.  Ensures completeness, accuracy, and compliance to all applicable GMP and GDP regulations.  
• Handles compilation of quality metrics for trending and follow up for the closure of process improvements. Presents and communicates trending reports in respective Quality forums.
• Supports training of Insmed employees in QMS processes; on time adherence of metrics, curriculum optimization, follow up on issues and training KPI`s.
• Uploads and routes Quality Records for approval in Veeva Quality Documents electronic documentation system.
• Performs QA Document Control review and approval of document updates.
• Ensures QMS records comply with process requirements, including use of appropriate document templates, where applicable.
• Monitors documents for Periodic Review process and works with document owners to ensure timely document review and update, as applicable.
• Assists in inspection readiness activities and plays a key role during inspections/audits for QMS activities.
• Provides support during internal review, Audits of Health Authorities and Third-party consultant Audits.
• Tracks and identifies trends of quality events, including but not limited to Change Controls, Deviations, CAPAs.
• Participation in global QMS content and training forums as EU representative (dotted line reporting into global process owner)

Position requirements :

• BS degree in Chemistry, Engineering, Life Science or related discipline required.
• A minimum of 3 years of relevant Quality Assurance experience required.
• Direct experience with Change Control, Document Control, Deviations, CAPAs, Effectiveness Checks and Training (management) in pharmaceutical or medical device products.
• Understanding of GMP and GDP for pharmaceutical products.
• Familiarity of pharmaceutical product manufacturing processes, medical devices.
• Experience working with an electronic document management system (EDMS).
• Experience at reviewing procedural documents, change controls, manufacturing investigations.
• Demonstrate ability to manage projects and variable workloads.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Proficient in analyzing data trends in Excel or Minitab.
• Travel may be occasionally required.

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

 

 

Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.

 

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.