Deciphera Pharmaceuticals
pharma, biotech, or life sciences
AssociateDirector,ITCSVandCompliance
“Associate Director, IT CSV and Compliance at Deciphera Pharmaceuticals. Skills: IT CSV and Compliance, GxP, GDPR, HIPAA. establish and oversee a robust, risk-based validation program supporting our regulated systems and data across the enterprise. ensure computerized systems remain compliant, inspection-ready, and aligned with global regulations”
What You'll Achieve.
ensure computerized systems remain compliant, inspection-ready, and aligned with global regulations
Industry & Context.
What They're Looking For.
Must Have
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, knowledge of data integrity, validation lifecycle management, and regulated system governance, Excellent communication and cross-functional leadership skills
Nice to Have
advanced degree preferred
What You'll Do.
establish and oversee a robust
risk-based validation program supporting our regulated systems and data across the enterprise
ensure computerized systems remain compliant
and aligned with global regulations
lead our Computerized System Validation (CSV) / Computer Software Assurance (CSA) framework
serving as the primary IT compliance lead for FDA
and internal audits and inspections
ensure validation lifecycle governance across system implementations
Lead and continuously improve the enterprise CSV/CSA framework
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
and follow-up activities
Provide oversight of validation activities across system lifecycles
Ensure GxP systems remain in a validated state while supporting cybersecurity
and business system initiatives
How You'll Work.
Team & Collaboration
partner closely with Quality, IT, Security, Privacy, and business stakeholders
Communication Scope
Excellent communication
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