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 2025, we became Great Place to Work-certified in the U.S. for the fifth 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.

 

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.

Responsibilities:

• 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

Position Requirements:Education and Experience:

• 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.

$88,000 - $122,467 a year

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. 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.