Job Description
- 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
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