Sr. Manager - Global Quality GxP Data Integrity SME

Bristol Myers Squibb • New Brunswick, NJ

1d • Hybrid

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Principal Objective of the Position Provide GxP subject matter expertise to support an effective and knowledgeable GxP Data Integrity Governance tower within the Global Quality GxP Data Integrity organization, with a focus on remediation activities being performed at the sites and functions. Accountable for helping establish and maintain an end-to-end (PDS and R&D) Data Integrity Governance program to ensure that regulatory and BMS requirements are addressed thoroughly and effectively in a timely manner. Additionally, may support oversight for the management of electronic records and/or electronic signatures in compliance with worldwide health authority regulations.

Requirements

• A minimum of 6 years of experience in the pharmaceutical industry.
• A minimum of 4 years of experience and in-depth knowledge of Data Integrity requirements.
• A minimum of 3 years of experience and in-depth knowledge of GxP computer system validation (CSV) and Part 11 requirements.
• University Graduate; Life-Sciences degree preferred.

Responsibilities

• In conjunction and at the direction of the Director of the GxP Data Integrity Program, provide day to day support for the governance, management, and coordination of activities related to the Data Integrity & Data Governance Program including implementing and maintaining Data Integrity compliance activities across the end-to-end product lifecycle (GPS and R&D) and across all BMS sites and internal functions in alignment with relevant governmental regulations and guidelines.
• Responsible for developing, reviewing, and approving appropriate BMS policies and procedures and coordinating all relevant activities between Quality, IT, and other departments in relation to implementation, maintenance, and change management of assigned programs.
• Support and manage remediation efforts across the network, utilizing QRM based principles to identify risk and establish appropriate prioritization.
• Provide active support during regulatory agency and third-party inspections.
• Support and conduct data integrity progress meetings across the network. This may include leading/supporting specific site- or organizational-group data integrity assessments and remediations, as applicable.
• Develop and utilize metrics and KPIs to ensure program success and maturity.
• Assist in conducting data integrity maturity assessments, developing remediation plans and strategies, and managing tasks to completion.
• Support foundational Data Governance activities for quality critical data, including identification of data ownership, standards, quality expectations, and performance metrics, in alignment with Global Quality priorities.
• Provide subject matter input to ensure Data Governance practices reinforce and sustain Data Integrity expectations across the data lifecycle, including integration of governance considerations into digital and analytics initiatives impacting GxP data.
• Enable data‑driven insights by reviewing and interpreting R&D Quality data, identifying trends and improvement opportunities, and partnering with RDQ pillars and BI&T to deliver clear, actionable KPIs and dashboards that drive visibility, accountability, and action.
• Identify and support opportunities to improve Data Integrity processes and oversight through responsible use of advanced analytics and AI‑enabled tools, enhancing risk identification, trend detection, and consistency.
• Ensure compliance with all Company policies and procedures, including safety rules and regulations.
• Support the development of standardized tools and training.
• Benchmarks within and outside of the Company, including regulatory agencies, business partners, and suppliers.
• Support the various audit programs across and within departments around data integrity concepts and training.
• Adherence to BMS core behaviors.
• GQ GxP Data Integrity Community of Practice meetings
• GQ GxP-DI departmental meetings
• Interface meetings with the site and functional areas supported
• Departmental meetings and senior management meetings
• IT Quality and Compliance Council

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level