Sr. Manager Global Quality GxP Data Integrity SME

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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.

Key Responsibilities and Major Duties

• 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.

General Activities

• 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 datadriven 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 AIenabled 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.

Meeting Participation

• 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

Key Stakeholders/Contacts

• Members of GQ GxP DI department

• Members of the GQ DQG (Digital Quality and Governance)

• Direct (as needed) or contracted reports

• Management and staff from the GPS and R&D departments involved in GxP-regulated operations (sites/functions)

• IT Quality Management Services

  • Validation Services

  • Service and Provider Quality Management

  • Contracted Enterprise Service partners.

• Management and staff directly responsible for the business operations of computerized systems

• Information Technology staff at commensurate levels of the organizations

• Management of the associated quality departments

• Inspectors during the conduct of health authority inspections

Experience 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.

Degree Requirements

• University Graduate; Life-Sciences degree preferred.

#LI-Hybrid

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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