Associate Director, IT Validation at Sarepta Therapeutics

Andover, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

201000.0

Posted On

18 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Computer System Validation, Computer Software Assurance, GxP, Data Integrity, Risk-based validation, Quality Assurance, Regulatory compliance, FDA regulations, EMA regulations, GAMP 5, 21 CFR Part 11, EU Annex 11, Polarion ALM, System lifecycle management, Change control, CAPA

Industry

Biotechnology Research

Description

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 diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re 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: https://www.sarepta.com/join-us The 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 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. 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? We’re always looking for solution-oriented, critical thinkers. So, if you’re 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 Blank 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 $160,800 - $201,000 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. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Responsibilities

Lead CSV/CSA activities and ensure GxP computerized systems are validated and maintained in compliance with regulatory requirements. Partner with IT, business teams, and Quality Assurance to drive risk-based validation strategies and manage system lifecycle deliverables.