Director, Quality Assurance AI/ML Systems

Insmed Incorporated • NJ Corporate Headquarters, NJ

29d • $177,000 - $242,000 • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree (BS) in Life Sciences, Computer Science, Data Science, Engineering, Pharmacy, or a related scientific or technical discipline required.
• 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.
• 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.

Nice To Haves

• 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.
• Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA.

Responsibilities

• Partner with business stakeholders across Insmed to understand AI/ML use-case needs and translate them into compliant, risk-proportionate QA solutions.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director