Manager, QC Computer System Validation

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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 rich in diversity. 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

Bristol Myers Squibb in Devens, MA is searching for a Quality Control (QC) Computer System Validation (CSV) Manager to join our Quality team. As the Manager, QC Computer System Validation, you will provide technical leadership and qualification/validation support for the fast paced, cross-functional Quality Control lab department. This position is an integral part of the Quality Shared Services Instrument Lifecycle (QSSIL) team and reports directly to the Senior Manager, QSSIL.

This position requires on-site presence; hybrid 50/50 or 75/25 (on site/WFH).

Responsibilities:

• Leads execution of CSV/validation activities for qualification of new/modified/upgraded QC instrumentation

• Designs, manages, and implements applicable validation documents, such as generic/custom software test scripts, User Requirement Specification (URS), Design Qualification (DQ), validation plans, Data Integrity (DI) assessments, risk assessments, configuration specifications, and qualification summary reports.

• Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/PAs).

• Participates in an Instrument Lifecycle Community of Practice to include multiple commercial QC sites, with a focus on sharing best practices, identifying key risks, reviewing regulatory and inspection trends, and driving towards lifecycle/qualification standardization.

• Owns change controls impacting QC equipment/software

• Acts as the liaison between Digital Plant (IT) and lab departments

• Performs periodic assessments/decommissioning

• Coordinates with external vendors for support

Qualifications:

• Bachelor’s degree in relevant scientific, engineering, or computer-based area with 3-6 years’ experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience

• Working knowledge of laboratory systems much as Empower, NuGenesis and other software programs, including Microsoft Office Applications, preferred.

• Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery

• Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects

• Demonstrated success in cross functional influencing, strong communication, and collaboration skills

• Quality management system experience including document control/management, change controls, investigations, deviations, electronic validation databases, asset management database

• Organizational/team leadership a plus

• Audit experience is a plus

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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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