Sumitomo Pharma America, Inc.
We are united in our mission to deliver patient-needed therapies sooner.
Associate Director, IT Compliance, Governance
Location
New York + 1 moreAll locations: New York, Massachusetts
Posted
65 days ago
Salary
$152K - $190K / year
Bachelor Degree8 yrs expEnglishCyber Security
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
Job 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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