Senior Specialist, Compliance Operations - Princeton, NJ

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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.
Summary/Scope

Bristol Myers Squibb (BMS) is a global biopharmaceutical company engaged primarily in the discovery development and commercialization of novel therapies for the treatment of human diseases.

The Lab Planning and Execution group is part of the Translational Science (TS) team within Translational Medicine (TM). TS leads internal and external diagnostic research & development activities to support multiple disease areas of interest including hematological malignancies inflammatory disease programs neuroscience cardiovascular fibrosis and solid tumor indications. The TS team integrates scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and health care providers we serve.

This position Senior Specialist reports to the Director Lab Planning and Execution and is accountable to support broad compliance activities to ensure regulations standards and requirements are met based on intended use of each laboratory within TM. The position supports the overall management of reagent consumables and equipment for the TM CLIA Laboratory. The position is to serve as a support and training resource for TS scientists using the LIMS and provide Quality Management System (QMS) role support within other applications and databases. The employee is required to provide cross-functional coordination support and work with cross-functional stakeholders for various compliance and/or operational efforts in support of the BMS pipeline.

Summary/Scope

Bristol Myers Squibb (BMS) is a global biopharmaceutical company engaged primarily in the discovery development and commercialization of novel therapies for the treatment of human diseases.

The Lab Planning and Execution group is part of the Translational Sciences (TS) team with Translational Medicine (TM). TS leads internal and external diagnostic research & development activities to support multiple disease areas of interest including hematological malignancies inflammatory disease programs neuroscience cardiovascular fibrosis and solid tumor indications. The TS team integrates scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and health care providers we serve.

This position Senior Specialist reports to the Director Lab Planning and Execution and is accountable to support broad compliance activities to ensure regulations standards and requirements are met based on intended use of each laboratory within TM. The position supports the overall management of reagent consumables and equipment for the TM CLIA Laboratory. The position is to serve as a support and training resource for TS scientists using the LIMS and provide Quality Management System (QMS) role support within other applications and databases. The employee is required to provide cross-functional coordination support and work with cross-functional stakeholders for various compliance and/or operational efforts in support of the BMS pipeline.

Roles and responsibilities include but are not limited to the following:

Supports broader compliance efforts across TM to ensure the requisite GxP standards are applied based on the intended use of the lab.

Supports activities to maintain state of audit/inspection readiness of TM CLIA Laboratory; may participate in laboratory walkthroughs QC of associated documentation and/or audits/inspections/site visits.

Performs incoming inspection and supports labeling and reagent release activities for TM CLIA Laboratory.

Partners with TM CLIA Laboratory Supervisors and staff to manage reagent and/or equipment inventory in LIMS.

Partners with TS and IT SMEs to support LIMS onboarding training and troubleshooting for TS and TM CLIA Laboratory staff.

Supports TM CLIA Laboratory supplier (vendor) management activities according to established processes.

Provides cross-functional coordination support to ensure TM CLIA Laboratory departmental and enterprise business goals and objectives are met.

Supports management of various Quality Management Systems (QMS) associated within TM.

Provides document management support within Electronic Document Management System (EDMS).

Assure that BMS values are demonstrated in all aspects of individual actions and team interactions.