Associate Director, IT CSV and Compliance

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.

Key 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.

Qualifications :

Qualifications

• Bachelors 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.

Additional Information :

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $171000 - $235000. Actual compensation packages will depend on various factors including but not limited to depth of experience education skillset overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus a long-term incentive plan full range of benefits and other incentive compensation plans (if applicable)

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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Remote Work :

No

Employment Type :

Full-time