Csv Quality Manager Jobs (NOW HIRING)

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Director, AI Architecture & Governance is a senior technical leadership role responsible for defining and governing enterprise-scale AI and Generative AI architectures across the life sciences value chain. This role establishes the standards, platform/tooling strategy, and governance frameworks required to deliver AI outcomes safely and at scale, while enabling AI/ML engineering resources to execute efficiently. The Director partners closely with Enterprise Systems, Computer System Validation (CSV), and Enterprise Data Systems (EDS) to ensure AI solutions align with application architecture, validation expectations, and enterprise data governance. Success requires strong cross functional collaboration and communication across scientists, engineers, data teams, and executive stakeholders.

• Enterprise AI Strategy and Architecture: Define and maintain the enterprise AI reference architecture (data, model, orchestration, and integration patterns) to support scalable delivery across R&D, clinical, and operations.
• Platform Strategy and Tooling: Lead build vs. buy vs. partner decisions and define approved tooling and platform patterns for AI/ML and agentic capabilities.
• Governance, Validation, and Compliance: Establish governance and validation standards for AI/ML solutions, including traceability, auditability, and human oversight, in alignment with CSV and applicable regulatory expectations.
• Data Governance and Security: Define data access and security models for AI systems and partner with EDS to ensure alignment with data governance standards, data ownership, and data quality controls.
• Portfolio Execution Oversight (Not Prioritization): Maintain oversight of the AI use case portfolio to ensure consistent execution against standards and measurable outcomes; business stakeholders set prioritization.
• Cross-Functional Adoption and Alignment: Drive alignment across teams by defining ownership boundaries and ensuring architectural standards translate into implementable patterns and adoption plans.

Bachelor’s degree required; advanced degree in a quantitative or technical field preferred.

• BA/BS degree with 12+ years of related experience
• MA/MS degree with 10+ years of related experience
• 8+ years of experience in AI/ML, data platforms, or enterprise architecture roles, including ownership of reference architectures and cross-team standards.
• Experience evaluating platforms/tools and driving adoption in complex enterprise environments.

• Strong understanding of AI/ML system architecture and integration patterns.
• Experience with modern data platforms and cloud architectures.
• Knowledge of governance, security, and access control models for enterprise data and AI systems.
• Ability to define scalable patterns for model lifecycle management, auditability, and operationalization.

• Track record of influencing cross-functional teams without formal authority.
• Excellent communication skills—able to bridge scientists, engineers, CSV/quality partners, and executives.
• Execution-oriented leadership—able to translate standards into practical implementation patterns.
• Ability to foster an inclusive, collaborative environment and build trust with diverse stakeholders.

• Experience in biotech/pharma and familiarity with R&D and clinical workflows.
• Experience working in regulated environments, including collaboration with CSV/quality organizations.
• Experience partnering with data governance organizations on data ownership, quality, and access controls.

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $206,000 - $257,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.