Associate Director of IT Compliance and Governance
Sumitomo Pharma, Annapolis, Maryland, United States, 21403
Join Sumitomo Pharma Co., Ltd. , a leading global pharmaceutical company dedicated to transforming patient care in various therapeutic areas including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a commitment to accelerating the development of innovative therapies, we invite you to be part of our mission to enhance healthcare and improve lives worldwide.
About the Role
We are seeking a dynamic Associate Director to lead our IT compliance and governance initiatives. In this role, you will play a crucial part in ensuring that our IT systems meet rigorous regulatory standards within the pharmaceutical industry. You will manage IT risks, oversee business continuity, and disaster recovery processes, while collaborating closely with cross-functional teams to maintain secure, compliant, and audit-ready systems.
Your Responsibilities
Regulatory Compliance & GxP Oversight
Ensure IT systems supporting GxP processes align with FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements.
Maintain comprehensive IT compliance documentation, including validation protocols, SOPs, and audit trails.
Manage periodic IT compliance assessments and remediation plans.
Support the ISO 27001 compliance by monitoring control effectiveness and coordinating documentation for audits.
Governance & Risk Management
Develop and implement IT governance frameworks aligned with industry standards and corporate policies.
Conduct IT risk assessments for systems in clinical, manufacturing, and commercial operations.
Formulate and execute risk mitigation strategies, maintaining detailed risk registers.
Business Continuity & Disaster Recovery
Lead the enterprise BC/DR program for IT systems.
Design, update, and test disaster recovery plans ensuring resilience of critical systems.
Collaborate with various business units to synchronize continuity strategies with operational needs.
Meet regulatory requirements for BC/DR in pharmaceutical settings.
Audit & Inspection Readiness
Act as the primary IT liaison for internal audits and regulatory inspections.
Promptly address audit findings while advancing our compliance posture.
Policy & Standards Development
Establish robust IT policies for data integrity, cybersecurity, and system lifecycle management.
Promote consistent governance application across both GxP and non-GxP systems.
Training & Awareness
Develop and implement IT compliance training programs for staff.
Foster a culture of compliance and resilience throughout IT and business teams.
Cross-Functional Collaboration
Collaborate with Quality, Regulatory, Clinical, and Manufacturing teams to ensure compliance in IT solutions.
Advise on regulatory implications for new technologies and initiatives.
Your Qualifications
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 pharmaceutical or life sciences sectors. Strong knowledge of GxP regulations and global compliance frameworks. Demonstrated experience in managing audits, inspections, and BC/DR programs in regulated environments. Key Skills and Competencies In-depth understanding of IT systems validation, data integrity principles, and cybersecurity controls. Exceptional communication and stakeholder management abilities. Capable of influencing and leading cross-functional teams. Preferred Certifications: CISA, CRISC, CGEIT ITIL Foundation GAMP 5 certification or knowledge CBCP (Certified Business Continuity Professional) or equivalent The base salary for this position ranges from $152,000 to $190,000, accompanied by opportunities for merit-based raises and a comprehensive total rewards package, including medical, dental, and vision insurance, 401(k) participation, and a generous time-off policy. Total compensation will reflect the unique qualifications of each candidate. This position requires the ability to handle multiple demands in a fast-paced environment, requiring strong independent judgment and excellent written and oral communication skills. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity employer. We encourage applications from individuals of all backgrounds and identities. Join us in creating a healthier future for all.
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 pharmaceutical or life sciences sectors. Strong knowledge of GxP regulations and global compliance frameworks. Demonstrated experience in managing audits, inspections, and BC/DR programs in regulated environments. Key Skills and Competencies In-depth understanding of IT systems validation, data integrity principles, and cybersecurity controls. Exceptional communication and stakeholder management abilities. Capable of influencing and leading cross-functional teams. Preferred Certifications: CISA, CRISC, CGEIT ITIL Foundation GAMP 5 certification or knowledge CBCP (Certified Business Continuity Professional) or equivalent The base salary for this position ranges from $152,000 to $190,000, accompanied by opportunities for merit-based raises and a comprehensive total rewards package, including medical, dental, and vision insurance, 401(k) participation, and a generous time-off policy. Total compensation will reflect the unique qualifications of each candidate. This position requires the ability to handle multiple demands in a fast-paced environment, requiring strong independent judgment and excellent written and oral communication skills. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity employer. We encourage applications from individuals of all backgrounds and identities. Join us in creating a healthier future for all.