Associate Director, IT CSV and Compliance

Deciphera Pharmaceuticals • Waltham, MA

1d • Hybrid

About The Position

We are seeking an experienced IT Compliance leader to establish and oversee a robust, risk-based validation program supporting our regulated systems and data across the enterprise. This role ensures computerized systems remain compliant, inspection-ready, and aligned with global regulations including GxP, GDPR, HIPAA, and other privacy requirements.
The Associate Director will lead our Computerized System Validation (CSV) / Computer Software Assurance (CSA) framework, serving as the primary IT compliance lead for FDA, EU, partner, and internal audits and inspections. This individual will partner closely with Quality, IT, Security, Privacy, and business stakeholders to ensure validation lifecycle governance across system implementations, changes, integrations, and retirements.

Requirements

• Bachelor’s degree in IT, Engineering, Life Sciences, or related field (advanced degree preferred).
• 5+ years of experience in regulated IT environments within pharma, biotech, or life sciences.
• 5+ years of leadership experience in CSV/CSA and GxP compliance.
• Direct experience supporting FDA and EU regulatory inspections.
• Strong knowledge of data integrity, validation lifecycle management, and regulated system governance.
• Excellent communication and cross-functional leadership skills.

Responsibilities

• Lead and continuously improve the enterprise CSV/CSA framework, including policies, standards, templates, and governance processes.
• Define and implement risk-based validation strategies aligned with regulatory expectations and CSA principles.
• Serve as IT lead during regulatory inspections and audits, ensuring inspection readiness and managing responses, CAPAs, and follow-up activities.
• Provide oversight of validation activities across system lifecycles, including change control, periodic reviews, vendor oversight, and SaaS/cloud platforms.
• Ensure GxP systems remain in a validated state while supporting cybersecurity, infrastructure, and business system initiatives.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

What This Job Offers

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