Associate Director of IT Compliance and Governance
Sumitomo Pharma, Phoenix, Arizona, United States, 85003
Join Sumitomo Pharma Co., Ltd., a global leader in pharmaceuticals specializing in addressing patient needs across multiple therapeutic areas including oncology, urology, women's health, and more. We are dedicated to accelerating the development of innovative therapies that enhance patient outcomes. This is an exciting opportunity to be a part of our mission to create value through groundbreaking research and development.
Job Overview
We are seeking a skilled Associate Director of IT Compliance and Governance to lead our IT compliance and governance efforts within a regulated pharmaceutical environment. This role is crucial for ensuring adherence to global regulations such as GxP, FDA, and EMA, managing IT risk, and overseeing our Business Continuity and Disaster Recovery programs. You will collaborate closely with our Quality Assurance, Regulatory Affairs, and IT teams to ensure our systems remain secure, compliant, and ready for audit.
Key Responsibilities
Regulatory Compliance & GxP Oversight:
Ensure IT systems supporting GxP processes comply with FDA 21 CFR Part 11, EU Annex 11, and relevant regulations. Maintain all compliance documentation and oversee periodic assessments and remediation plans. Governance & Risk Management:
Develop and manage IT governance frameworks as per industry standards. Conduct IT risk assessments and implement effective risk mitigation strategies. Business Continuity & Disaster Recovery (BC/DR):
Own the BC/DR program for IT systems. Develop, maintain, and test disaster recovery plans to ensure rapid recovery of critical systems. Audit & Inspection Readiness:
Act as the primary IT contact for audits and inspections, ensuring prompt resolution of findings. Policy & Standards Development:
Establish and enforce IT policies and standards to uphold data integrity and cybersecurity. Training & Awareness:
Design and implement training programs for IT compliance and BC/DR to promote a culture of compliance. Cross-Functional Collaboration:
Work alongside Quality, Regulatory, Clinical, and Manufacturing teams to support compliance and continuity in IT solutions. Qualifications Education:
Bachelor’s degree in Information Technology, Computer Science, or a related field; advanced degrees preferred. Experience:
Over 8 years in IT compliance, governance, or risk management in the pharmaceutical or life sciences sector. Strong familiarity with GxP, FDA regulations, and auditing processes is essential. Core Competencies: In-depth knowledge of IT systems validation, data integrity, and cybersecurity best practices. Excellent communication abilities and strong stakeholder management skills. Proven ability to influence and lead cross-functional teams effectively. Preferred Certifications: CISA, CRISC, CGEIT; ITIL Foundation; GAMP 5 knowledge; CBCP or equivalent. The base salary for this position ranges from $152,000 to $190,000. This role offers a comprehensive benefits package including merit-based salary increases, a short incentive plan, 401(k) plan eligibility, and various insurance coverages. Our time-off policy is generous, including flexible paid time off and additional leave during our end-of-year shut-down. Salary offers depend on candidate experience, skills, and other factors as permitted by law. Equal Employment Opportunity:
Sumitomo Pharma America is an equal opportunity employer. Qualified candidates will not be discriminated against due to race, religion, gender, age, or any other characteristic protected by law. If you require assistance with the application process, please contact us at the specified email for accommodations.
Ensure IT systems supporting GxP processes comply with FDA 21 CFR Part 11, EU Annex 11, and relevant regulations. Maintain all compliance documentation and oversee periodic assessments and remediation plans. Governance & Risk Management:
Develop and manage IT governance frameworks as per industry standards. Conduct IT risk assessments and implement effective risk mitigation strategies. Business Continuity & Disaster Recovery (BC/DR):
Own the BC/DR program for IT systems. Develop, maintain, and test disaster recovery plans to ensure rapid recovery of critical systems. Audit & Inspection Readiness:
Act as the primary IT contact for audits and inspections, ensuring prompt resolution of findings. Policy & Standards Development:
Establish and enforce IT policies and standards to uphold data integrity and cybersecurity. Training & Awareness:
Design and implement training programs for IT compliance and BC/DR to promote a culture of compliance. Cross-Functional Collaboration:
Work alongside Quality, Regulatory, Clinical, and Manufacturing teams to support compliance and continuity in IT solutions. Qualifications Education:
Bachelor’s degree in Information Technology, Computer Science, or a related field; advanced degrees preferred. Experience:
Over 8 years in IT compliance, governance, or risk management in the pharmaceutical or life sciences sector. Strong familiarity with GxP, FDA regulations, and auditing processes is essential. Core Competencies: In-depth knowledge of IT systems validation, data integrity, and cybersecurity best practices. Excellent communication abilities and strong stakeholder management skills. Proven ability to influence and lead cross-functional teams effectively. Preferred Certifications: CISA, CRISC, CGEIT; ITIL Foundation; GAMP 5 knowledge; CBCP or equivalent. The base salary for this position ranges from $152,000 to $190,000. This role offers a comprehensive benefits package including merit-based salary increases, a short incentive plan, 401(k) plan eligibility, and various insurance coverages. Our time-off policy is generous, including flexible paid time off and additional leave during our end-of-year shut-down. Salary offers depend on candidate experience, skills, and other factors as permitted by law. Equal Employment Opportunity:
Sumitomo Pharma America is an equal opportunity employer. Qualified candidates will not be discriminated against due to race, religion, gender, age, or any other characteristic protected by law. If you require assistance with the application process, please contact us at the specified email for accommodations.