Description

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 four 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:
We are looking for someone to work in a hybrid capacity, aligned to either our Bridgewater, NJ or San Diego location.

The Sr. Quality Engineer, Digital Systems Quality Assurance (QA), is responsible for providing quality oversight of GxP computerized systems throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulatory requirements. This role will support implementation and ongoing management of digital systems used in clinical trial operations, quality control laboratories and other GxP areas, with a focus on data integrity, validation, and inspection readiness. The Sr. Quality Engineer will partner with IT, business, and vendor teams to apply risk-based approaches, maintain validated state, and drive continuous compliance in support of patient safety and product quality. The position requires proficiencies in key Quality Systems Process such as Change Control, Deviation, CAPA, Supplier Quality, Internal/External Audit, Quality Complaints and Production Process Control.

What You'll Do:

• Provide Quality Assurance oversight for GxP computerized systems across their lifecycle (implementation, operation, maintenance, and retirement) to ensure compliance with FDA, ICH, and EU regulations.
• Review and approve computer system validation (CSV) deliverables (e.g., URS, FS, validation plans, protocols, reports, and test evidence).
• Ensure compliance with 21 CFR Part 11, Annex 11, data integrity, and electronic records/electronic signature requirements.
• Collaborate with IT System Owner, Business Owners, and validation teams to ensure risk-based approaches are applied in system qualification and validation.
• Perform QA review of change control, deviations, CAPAs, and periodic reviews for computerized systems.
• Support development, review, and approval of SOPs, work instructions, and procedural documents related to computerized system lifecycle management.
• Provide QA support during supplier qualification, audits, and system implementation projects, including SaaS/cloud-based solutions.
• Partner with stakeholders for computer system lifecycle management activities to ensure that GxP computer systems remain in a validated and compliant state.
• Participate in inspection readiness activities and provide support during regulatory inspections.
• Monitor industry trends, regulatory updates, and guidance documents to ensure QA practices remain current and compliant.
• Provide training and guidance to business and IT stakeholders on quality and compliance expectations for GxP computerized systems.
• Role-related 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

Who You Are:

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field preferred.
• 5+ years of experience in Quality Assurance, Validation, within the FDA-regulated pharmaceutical or biotech industry.

Technical Knowledge:

• Strong understanding of GxP regulations (FDA, EMA, ICH) and applicable guidelines for computerized systems (21 CFR Part 11, Annex 11, GAMP 5).
• Hands-on experience with computer system validation (CSV) and lifecycle management in clinical and/or laboratory environments.
• Knowledge of clinical systems (e.g., EDC, IRT, eTMF, CTMS) and/or QC laboratory systems (e.g., LIMS, CDS, ELN, Empower) strongly preferred.
• Experience with On-premise/SaaS/cloud-hosted systems and supplier management, including supplier audits and qualification
• Understanding of data integrity principles and ALCOA+ requirements.
• Quality Professional Certificates such as ASQ Certified Software Quality Engineer, ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, preferred.

Skills and Abilities:

• Demonstrated ability to review and approve validation deliverables, protocols, and procedural documents as QA with a strong attention to detail.
• Proven ability to collaborate across IT, QA, and business functions, and to provide clear compliance guidance in project and operational settings.
• Strong organizational, analytical, and problem-solving skills with the ability to make independent, risk-based decisions.
• Excellent written and verbal communication skills; able to interact effectively with stakeholders at all levels.

Pay Range:
$88,000.00-122,467.00 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.

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.

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.