Sr Quality Engineer Digital System QA

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 patientsfirst 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 Sciences 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. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences 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 Workcertified 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.

• Guide Business Owners and IT System Owners for computer systems validation and lifecycle management deliverables as Digital Systems QA in accordance with applicable regulations guidelines policies and procedures.
• Facilitate Computer System Life Cycle Management activities such as IT Change Control System Releases/Upgrades Periodic Reviews Audit Trail Review User Access Review Incidents as Digital System QA.
• Train assist and advise business users on executing GxP computer system validation life cycle management activities within EDMS/QMS.
• Lead GxP IT Change Control cross functional forum assessing GxP Computer System changes to be implemented for continuous improvement.
• Authors SOPs and Quality System records such as Document Change Control Change Control Deviation CAPA Audit Observations Risk Assessments Periodic Review and assists other departments with the generation review approval and maintenance of such records.
• Provide support during regulatory inspections internal audits and supplier qualifications.
• Experience with Veeva systems is preferred.
• Experience implementing validating and controlling GxP Computer Systems in validated state in an FDA or equivalent regulated settings.
• Rolerelated knowledge: Working knowledge of all GxP regulations and guidances including 21 CFR Part 11 Annex 11 ICH Harmonized Guideline Good Clinical Practice (GCP) E6(R3 Computerized Systems Used in Clinical Trials Computer System Validation Quality Management Systems Processes (Change Control Deviation CAPA Audits Supplier Quality Production Process Control) and quality management tools.

• Education BS Degree required.
• A minimum of 5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered.
• Experience in working in a GxP regulated industry and preferably in Quality Assurance role.
• Experience as QA approver of GxP records and processes: Change Controls Computer System Validation Deliverables Deviations CAPA SOPs etc..
• Must be familiar with 21 CFR Part 11 Annex 11 GAMP 5 Data Integrity and SDLC (Agile or Waterfall).
• Quality Professional Certificates such as ASQ Certified Software Quality Engineer ASQ Certified Quality Engineer ASQ Certified Quality Auditor preferred.
• Must have excellent communication skills (verbal and written).
• Demonstrate ability to manage projects and variable workloads.
• Highly organized with a strong attention to details clarity accuracy and conciseness.
• Must successfully exhibit Insmeds five 5 core corporate values: Passion Accountability Collaboration Integrity and Respect; along with any other position specific competencies

At Insmed were committed to investing in every team members total wellbeing 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 timeoff plans
• Competitive compensation package including bonus
• Equity Awards (LongTerm Incentives)
• Employee Stock Purchase Plan (ESPP)

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

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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.

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 atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase 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.