Associate Director, IT Validation

Why Sarepta Why Now

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

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: Importance of the Role

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.

The Opportunity to Make a Difference

• 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.

More about You

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

What Now

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.

#LI-Hybrid

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This position is hybrid you will be expected to work on site at one of Sareptas 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 $160800 - $201000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.