Sumitomo Pharma America, Inc.

We are united in our mission to deliver patient-needed therapies sooner.

Associate Director, IT Compliance, Governance

ComplianceComplianceFull TimeRemoteTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

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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