Senior Manager, Stability LIMS Systems

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The Senior Manager of Stability LIMS Systems will support commercial Global Stability operations within multiple LIMS (Laboratory Information Systems) through development, management, and execution of stability strategies within the electronic system. The position will require extensive knowledge of LIMS systems (i.e. ThermoFisher Sample Manager and Labware) and stability programs and operations.

Role Responsibilities:

• Serve as point of contact for the stability user group to work with business and process owners with the intent on developing, managing, and executing stability strategies related to the electronic LIMS systems

• Serve as the Stability technical expert within the Sample Manager LIMS and Labware systems

• Support static builds, migrations, and system updates and harmonizations via user requirements

• Manage user ticket requests to ensure available stability support and completion

• Execute and/or manage completion of UAT (User Acceptance Testing) (for functionality changes)

• Support and drive, as necessary, system stability deviations, as warranted

• Training stability personnel on LIMS system usage

• Perform MDM (Master Data Management) Verifications

• General LIMS user support and initial/basic troubleshooting

• Change Control Support, including impact assessments on behalf of the Global Stability team

• Authoring and maintaining stability documentation (e.g. SOP, Work Instructions, Reports)

• Maintain and operate within cGMP (Good Manufacturing Practices) requirements, including maintaining training status

• Perform stability scientist duties, as needed (e.g. stability submission and program strategies, stability protocols, trending, managing product requirements)

• Perform against the company values: Accountability, Passion, Innovation, Integrity, Urgency, Inclusion

Role Requirements:

• Bachelor of Science (BS), at a minimum, with at least 10 years of experience within the pharmaceutical industry: at least 5 years of stability product/program experience and 5 years developing and executing LIMS strategies to support the stability program

• Must be able to understand stability process, quality, and integrated validated systems, in context of multiple LIMS systems

• Experience in generating, supporting, and completing change management records, including impact assessments

• Experience supporting deviations to drive through root cause analysis and evaluate potential system impact

• Experience working across departmental and functional lines

• Must be able to work across border, cultures and multiple time zones

• Must be able to operate within a global organization that encompasses different drug product platforms and multiple operational sites that support a vast supply chain network

• Strong understanding of GMP requirements

• Familiarity with Data Integrity principles is a requirement

• Familiarity and experience with Veeva, for deviation, change and document management, is a benefit

• Familiarity with Quality Risk Management is a benefit

• Fluency with the French language is a bonus

#LI-Hybrid

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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