New · posted Oct 15
Insmed · Pharmaceuticals
Director, Quality Assurance AI/ML Systems
- Bridgewater, NJ
- Hybrid
- Full-time
- Director
Open until filled
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.
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?
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.
- Hybrid
What you need
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; at least 3–5 years in a Director-level or senior leadership capacity.
- 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%
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.
Pay and benefits
$177,000 – $242,000 a year
Employer provided$177,000.00-242,000.00 Annual
Medical, dental, and vision coverage
Generous paid time off
401(k) with company match
Annual equity awards and ESPP
Company-paid life and disability insurance
Learning Institute and mentorship
Where you'll work
Bridgewater, NJHybridOpen in Maps (opens in a new tab)
More jobs in Bridgewater, NJ
From the posting
About Insmed
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.
Equal opportunity, accessibility and legal noticesInsmed's statements, word for word
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].
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in New Jersey9 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $177,000 | — | $242,000 |
| New Jersey (middle half) | $177,000 | $209,000 | $210,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Insmed's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Insmed's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- GMP and compliance9
- Validation and qualification8
- Data and digital systems6
- Quality systems and risk5
- Documentation and SOPs4
- Lab testing and methods3
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Insmed on Regulatory Jobs
- 13
- Open roles
- 13
- Distinct roles
- 3
- Locations
By discipline
- Quality8 62%
- Regulatory4 31%
- Compliance & Safety1 8%
By level
- Director7 54%
- Associate & Specialist3 23%
- Manager2 15%
More roles at Insmed
- View role
Summer Intern – CMC Quality Assurance, Clinical Programs
Remote, USAssociate & SpecialistPharmaceuticals$42K–$73K
- View role
Specialist, Quality CMC Operations
Bridgewater, NJ · HybridAssociate & SpecialistPharmaceuticals$81K–$104K
- View role
Manager, Product Quality Complaint Data Analytics
Bridgewater, NJ · HybridManagerPharmaceuticals$124K–$161K
- View role
Senior Director, Quality Assurance - Gene Therapy
San Diego, CA · HybridDirectorBiotechnology$214K–$292K
Similar Quality Assurance roles elsewhere
- View role
Senior Director Quality Digital & Analytics
Johnson & JohnsonNew Brunswick, NJ +1 moreDirectorPharmaceuticals$178K–$307K
- View role
Director, GCP Quality Assurance
ACADIA PharmaceuticalsPrinceton, NJ +2 more · HybridDirectorPharmaceuticals$166K
- View role
Associate Director, Quality Assurance - Technical
Travere TherapeuticsRemote, USDirectorPharmaceuticals$150K–$195K
- View role
Director, GMP Quality Assurance
Mirum PharmaceuticalsFoster City, CA · HybridDirectorPharmaceuticals$220K–$240K
Director, Quality Assurance AI/ML Systems at Insmed
Open until filled. $177K–$242K a year, employer provided.