Sr. Quality Engineer, Digital System QA

Company Description

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.

Recognitions

 

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.

  

 

Overview

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

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 p