Associate Director, IT Compliance, Governance
Job Description:
• Lead IT compliance and governance programs in a regulated pharmaceutical environment
• Ensure adherence to global regulations (GxP, FDA, EMA)
• Manage IT risk and oversee Business Continuity and Disaster Recovery
• Partner with QA, Regulatory, and IT teams to maintain secure, compliant, audit-ready systems
• Ensure IT systems support GxP processes and comply with relevant regulations
• Maintain IT compliance documentation and oversee periodic assessments
• Develop IT governance frameworks aligned with industry standards
• Conduct IT risk assessments and implement mitigation strategies
• Own and manage the enterprise BC/DR program for IT systems
• Serve as primary IT contact for audits, inspections, and assessments
• Establish IT policies and standards for data integrity and cybersecurity
• Develop and deliver IT compliance and BC/DR training programs
Requirements:
• Bachelor’s degree in Information Technology, Computer Science, or related field
• 8+ years in IT compliance, governance, or risk management within a pharmaceutical or life sciences environment
• Strong knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, and global regulatory frameworks
• Proven experience managing audits, inspections, and BC/DR programs in a regulated industry
• Preferred Certifications: CISA, CRISC, CGEIT, ITIL Foundation, GAMP 5 knowledge or certification, CBCP (Certified Business Continuity Professional) or equivalent
Benefits:
• Merit-based salary increases
• Short incentive plan participation
• 401(k) plan eligibility
• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Flexible paid time off
• 11 paid holidays
• Additional time off during shutdown period in December
• 80 hours of paid sick time upon hire and yearly thereafter
Apply Now
Apply Now
• Lead IT compliance and governance programs in a regulated pharmaceutical environment
• Ensure adherence to global regulations (GxP, FDA, EMA)
• Manage IT risk and oversee Business Continuity and Disaster Recovery
• Partner with QA, Regulatory, and IT teams to maintain secure, compliant, audit-ready systems
• Ensure IT systems support GxP processes and comply with relevant regulations
• Maintain IT compliance documentation and oversee periodic assessments
• Develop IT governance frameworks aligned with industry standards
• Conduct IT risk assessments and implement mitigation strategies
• Own and manage the enterprise BC/DR program for IT systems
• Serve as primary IT contact for audits, inspections, and assessments
• Establish IT policies and standards for data integrity and cybersecurity
• Develop and deliver IT compliance and BC/DR training programs
Requirements:
• Bachelor’s degree in Information Technology, Computer Science, or related field
• 8+ years in IT compliance, governance, or risk management within a pharmaceutical or life sciences environment
• Strong knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, and global regulatory frameworks
• Proven experience managing audits, inspections, and BC/DR programs in a regulated industry
• Preferred Certifications: CISA, CRISC, CGEIT, ITIL Foundation, GAMP 5 knowledge or certification, CBCP (Certified Business Continuity Professional) or equivalent
Benefits:
• Merit-based salary increases
• Short incentive plan participation
• 401(k) plan eligibility
• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Flexible paid time off
• 11 paid holidays
• Additional time off during shutdown period in December
• 80 hours of paid sick time upon hire and yearly thereafter
Apply Now
Apply Now