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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 https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

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.

Job Duties and Responsibilities

+ **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.

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 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.

Key Core Competencies

+ 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 Certifications:

+ 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** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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 https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]

This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our** **Mission

_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_

Our** **Vision

_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_