Sr. Manager - Global Quality GxP Data Integrity SME

Bristol Myers Squibb•New Brunswick, NJ

1d•Hybrid

About 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

Nice To Haves

Life-Sciences degree preferred

Responsibilities

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.
Develop, review, and approve appropriate BMS policies and procedures and coordinate 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, which 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.

Benefits

Medical care
Pharmacy care
Dental care
Vision care
BMS Well-Being Account
BMS Living Life Better program
Employee Assistance Programs (EAP)
401(k) plan
Short-term disability
Long-term disability
Life insurance
Accident insurance
Supplemental health insurance
Business travel protection
Personal liability protection
Identity theft benefit
Legal support
Survivor support
Flexible time off (unlimited, with manager approval, for US Exempt Employees)
11 paid national holidays (for US Exempt Employees, Phoenix, AZ, Puerto Rico or Rayzebio employees have different holiday rules)
160 hours annual paid vacation for new hires (for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees)
3 optional holidays (for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees)
Unlimited paid sick time (based on eligibility)
Up to 2 paid volunteer days per year (based on eligibility)
Summer hours flexibility (based on eligibility)
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day