Sumitomo Pharma America, Inc. · 6 days ago
Associate Director, IT Compliance & Governance
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$152K/yr - $190K/yr
8+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs. The role involves leading IT compliance and governance programs, ensuring adherence to global regulations, managing IT risk, and overseeing Business Continuity and Disaster Recovery.
Pharmaceuticals
Responsibilities
Ensure IT systems supporting GxP processes comply with FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations
Maintain IT compliance documentation including validation protocols, SOPs, and audit trails
Oversee periodic IT compliance assessments and manage remediation plans
Develop and maintain IT governance frameworks aligned with pharmaceutical industry standards and corporate policies
Conduct IT risk assessments for systems supporting clinical, manufacturing, and commercial operations
Implement risk mitigation strategies and maintain risk registers
Own and manage the enterprise BC/DR program for IT systems
Develop, maintain, and test disaster recovery plans to ensure resilience and rapid recovery of critical systems
Coordinate with business units to align continuity strategies with operational priorities
Ensure compliance with regulatory expectations for BC/DR in pharmaceutical environments
Serve as the primary IT contact for internal audits, regulatory inspections, and third-party assessments
Ensure timely resolution of audit findings and continuous improvement of compliance posture
Establish IT policies and standards for data integrity, cybersecurity, system lifecycle management, and BC/DR
Ensure consistent application of governance principles across GxP and non-GxP systems
Develop and deliver IT compliance and BC/DR training programs for system owners and end-users
Promote a culture of compliance and resilience across IT and business teams
Partner with Quality, Regulatory, Clinical, and Manufacturing teams to ensure IT solutions meet compliance and continuity requirements
Provide guidance on regulatory impacts for new technologies and digital initiatives
Qualification
Required
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
Deep understanding of IT systems validation, data integrity principles, cybersecurity controls, and BC/DR best practices
Excellent communication and stakeholder management skills
Ability to influence and lead cross-functional teams
Preferred
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
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Flexible paid time off
11 paid holidays plus additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase