Associate Director, IT Validation

Sarepta Therapeutics • Andover, MA

7h • Hybrid

About The Position

We are seeking a seasoned IT Validation/Quality Assurance professional with life sciences expertise to join our team as Associate Director, IT Validation. Reporting to the Director, IT Compliance and Processes, in this role, you will lead CSV/CSA activities and ensure that 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 guidelines/best practices. You will provide validation oversight as well as hands-on development of the computer system validation/computer software assurance lifecycle and associated deliverables from design and implementation to retirement. Acting as a strategic partner across IT, business teams and Quality Assurance, the ideal candidate will combine technical expertise, deep knowledge of CSV/CSA, strong quality systems acumen, exceptional cross-functional communication skills, and a proactive / self-starting mindset to drive risk-based validation strategies and enable compliant, efficient system implementations.

Requirements

• Bachelor’s or Master’s degree in software, computer engineering, life sciences or technical field or equivalent work experience.
• 8+ years of experience within clinical and commercial-stage pharmaceutical or biotech companies.
• Excellent attention to detail and strong organizational and communication skills, both written and verbal.
• Demonstrated expertise in GxP computerized system validation (CSV/CSA), risk-based validation methodologies and system lifecycle management.
• Hands-on experience with validating a broad spectrum of computerized systems platforms across R&D and Technical Operations, such as Veeva (RIM, Quality, Clinical, Safety, EDC, vault connectors), Oracle, Tracelink, LabVantage, Splashlake, Statistica, SAS, Pinnacle21, Posit products (Workbench, Connect).
• Extensive knowledge of regulatory requirements and industry best practices, including relevant 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).
• Working knowledge of current industry trends of the use of AI/ML tools in the regulated space.
• Experience with Polarion ALM or other validation life cycle management systems.
• Experience with audits and regulatory inspections.
• Ability to work independently and collaboratively within a team with minimal direction

Nice To Haves

• Knowledge of infrastructure qualification and IT security frameworks such as NIST, ISO/IEC, SOC 2 a plus.

Responsibilities

• Partner with IT, business owners, external vendors and Quality Assurance in the validation and delivery of new GxP computerized systems.
• Provide direct support for the CSV/CSA program, including the development, review, approval of risk assessments, validation deliverables, change controls and associated change actions.
• Serve as IT subject matter expert (SME) and provide guidance and direction on risk-based validation strategies.
• Support Quality Assurance activities including GxP computerized systems periodic reviews.
• Own CSV/CSA related deviations/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.

What This Job Offers

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