Associate Director, IT Validation

Position Summary

Associate Director, IT Validation. Reporting to the Director, IT Compliance and Processes, this role leads CSV/CSA activities and ensures GxP computerized systems across R&D and Technical Operations are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP and other relevant regulations.

• Lead CSV/CSA activities and ensure GxP computerized systems across R&D and Technical Operations are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP and other Health Authority requirements, good data integrity and data quality standards and industry best practices.
• Provide validation oversight and hands‑on development of the computer system validation/computer software assurance lifecycle and associated deliverables from design through retirement.
• Serve as a strategic partner across IT, business teams and Quality Assurance, combining technical expertise, deep knowledge of CSV/CSA, quality systems acumen, strong communication skills and a proactive mindset to drive risk‑based validation strategies.
• Partner with IT, business owners, external vendors and Quality Assurance to deliver new GxP computerized systems.
• Provide direct support for the CSV/CSA program, including the development, review and approval of risk assessments, validation deliverables, change controls and associated change actions.
• Serve as IT subject matter expert and provide guidance on risk‑based validation strategies.
• Support Quality Assurance activities including GxP computerized systems periodic reviews.
• Own CSV/CSA related deviations and CAPAs and manage remediation activities.
• Provide administrative and technical support for Polarion ALM.
• Support regulatory inspections and audits, ensuring adherence to 21 CFR Part 11, EU Annex 11, GxP, and other regulatory frameworks.
• Drive continuous improvement initiatives for validated GxP systems.
• Maintain awareness of current and upcoming CSV/CSA industry trends.

• Bachelor’s or Master’s degree in software, computer engineering, life sciences or a related technical field, or equivalent experience.
• 8+ years of experience within clinical and commercial‑stage pharmaceutical or biotech companies.
• Excellent attention to detail, strong organizational and communication skills.
• Demonstrated expertise in GxP computerized system validation (CSV/CSA), risk‑based validation methodologies and system lifecycle management.
• Hands‑on experience validating a broad spectrum of computer system platforms across R&D and Technical Operations, including Veeva, Oracle, Tracelink, Lab Vantage, Splash lake, Statistica, SAS, Pinnacle
  21, Posit products (Workbench, Connect).
• Extensive knowledge of regulatory requirements and industry best practices (FDA predicate rules, FDA CSA Guidance for Industry, 21 CFR Part 11, EU Annex 11, ICH guidelines, GAMP
  5).
• Working knowledge of SOX and privacy regulations (GDPR, HIPAA) and current industry trends of AI/ML tools in the regulated space.
• Knowledge of infrastructure qualification and IT security frameworks such as NIST, ISO/IEC, SOC 2 (a plus).
• Experience with Polarion ALM or other validation lifecycle management systems.
• Experience with audits and regulatory inspections.
• Ability to work independently and collaboratively within a team with minimal direction.

This is a hybrid position. The employee will be expected to work on site at one of Sarepta’s U.S. facilities and/or attend company‑sponsored in‑person events from time to time.

Sarepta offers a competitive compensation and benefit package, including support for caregivers, financial wellness resources and a range of physical and emotional wellness programs.

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