Sumitomo Pharma America, Inc.

Associate Director, IT Compliance, Governance

Sumitomo Pharma America, Inc.

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • New York • United States

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Salary

💰 $152,000 - $190,000 per year

Job Level

Senior

Tech Stack

Cyber Security

About the role

  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
IT compliancegovernancerisk managementBusiness ContinuityDisaster RecoveryGxP processesIT risk assessmentsdata integritycybersecurityaudit management
Soft skills
leadershipcommunicationcollaborationorganizational skillstraining development
Certifications
CISACRISCCGEITITIL FoundationGAMP 5CBCP