Associate Director, IT Compliance & Governance

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

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.

• Regulatory Compliance & GxP Oversight 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.
• Governance & Risk Management 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.
• Business Continuity & Disaster Recovery (BC/DR) 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.
• Audit & Inspection Readiness 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.
• Policy & Standards Development 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.
• Training & Awareness 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.
• Cross-Functional Collaboration 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.

• Education: Bachelor’s degree in Information Technology, Computer Science, or related field; advanced degree preferred.
• Experience: 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.

• CISA, CRISC, CGEIT
• ITIL Foundation
• GAMP 5 knowledge or certification
• CBCP (Certified Business Continuity Professional) or equivalent

The base salary range for this role is $152,000 to $190,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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.

Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data:
All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance:
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