Director of Digital Systems Quality Assurance: AI/ML Systems

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 five 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:

The Director of Digital Systems Quality Assurance (DSQA)- AI/ML is an enterprise-level role responsible for representing QA in the design, governance, and continuous improvement of a regulatory-compliant framework for Artificial Intelligence (AI) and Machine Learning (ML) solutions across Insmed’s global GxP-regulated digital landscape. This position serves as the lead for the assessment, classification, risk evaluation, validation, and implementation design of AI/ML-enabled systems, ensuring alignment with global regulatory expectations and Insmed’s quality standards.
Working in close partnership with IT System Owners, Business Owners, and CSV leads, this role drives a unified, risk-based approach to AI/ML quality oversight spanning all DSQA functional domains and Insmed sites. The position serves as the enterprise QA lead for regulated AI/ML solutions, providing independent QA review of Computer Software Validation lifecycle documents and facilitating site IT Change Control processes across all functional areas.

What You'll Do:

In this role, you will partner with business stakeholders across Insmed to understand AI/ML use-case needs and translate them into compliant, risk-proportionate QA solutions.

You will also have responsibility for:

• Support AI/ML-specific risk assessment methodologies aligned with GAMP 5, FDA AI/ML guidance, EU AI Act, Annex 11, and 21 CFR Part 11. 
• Represent Digital QA in cross-functional governance forums, steering committees, and working groups focused on AI/ML adoption and compliance. 
• Support the Development and maintenance of AI/ML-specific validation lifecycle documentation including AI/ML Risk Assessments, Validation Plans, Model Cards, Performance Qualification (PQ) protocols, and Ongoing Performance Monitoring (OPM) plans. 
• Ensure responsible AI principles are embedded in the design and governance of AI/ML solutions, including bias assessment, human oversight requirements, and transparency standards aligned with EU AI Act risk classifications 
• Ensure AI/ML models and systems deployed in GxP contexts maintain data integrity, auditability, explainability, and traceability in alignment with global regulatory expectations. 
• Provide QA oversight and governance guidance for Generative AI (GenAI) and agentic AI use cases in GxP-adjacent environments, including hallucination risk, non-determinism, prompt governance, and output auditability standards. 
• Define requirements for ongoing model monitoring, drift detection, retraining governance, and change control processes for AI/ML solutions in validated states. 
• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents. 
• Provide guidance, training, and mentoring to the Insmed team members on AI/ML concepts, regulatory expectations, validation approaches, and risk-based QA methodology.  Development of AI Training requirements (as necessary) 
• Lead or participate in AI/ML-related vendor assessments, audits, and qualification activities to ensure third-party AI/ML solutions meet Insmed’s quality and regulatory standards. Support regulatory inspections and internal/external audits as the AI/ML QA SME; prepare inspection-readiness materials and respond to agency questions on AI/ML topics. 

Who You Are:

You have a Bachelor’s degree (BS) in Life Sciences, Computer Science, Data Science, Engineering, Pharmacy, or a related scientific or technical discipline required. Advanced degree (MS, MBA, or PhD) in a relevant discipline preferred; candidates with an advanced degree and a minimum of 8 years of relevant experience will be considered 

Additionally you have:

• A minimum of 10 years of relevant Quality Assurance experience required.
• Demonstrated experience building, leading, or significantly contributing to AI/ML quality or validation frameworks in a regulated (FDA, EMA, or equivalent) environment.  
• Working knowledge of MLOps, AIOps and similar concepts and associated tools and concepts (e.g., model versioning, CI/CD, experiment tracking, drift monitoring platforms); familiarity with cloud-based AI/ML platforms (Vertex, Bedrock) and Data warehouse such as Snowflake preferred. 
• Hands-on experience with GxP computer system validation (CSV) and/or Computer Software Assurance (CSA) across multiple domains (clinical, manufacturing, laboratory, commercial). 
• Experience as QA reviewer of several GMP records and processes:  CSV Validation Protocols, Deviations, CAPA, SOPs, etc. 
• Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA 
• 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 Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies 

Travel Requirements

This role requires occasional domestic travel approximately 30% 

Where You’ll Work  

This is a hybrid role based out of our Bridgewater, NJ Headquarters. You’ll work remotely most of the time, with in-person collaboration when it matters most.

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Pay Range:

$177,000.00-242,000.00 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. 

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [email protected]  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.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected].