Quality Shared Services Instrument Lifecycle Senior Manager

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Instrument Lifecycle team provides operational and technical support to the QC laboratories by providing lifecycle support for QC analytical instrumentation and equipment. The Instrument Lifecycle Senior Manager oversees the execution of instrument processes to support the lifecycle management of instrumentation. The role provides technical leadership in handling instrumentation issues, and partners with all levels of laboratory personnel, Validation Services, Quality Assurance and Facilities & Engineering to ensure instrument reliability.

This position will be 100% onsite

Duties/Responsibilities:

• Coordinate the execution of day-to-day activities of the instrument lifecycle team to ensure activities are aligned with department needs and site goals.

• Ensures that all GMP compliance requirements are being met regarding laboratory instrumentation and equipment.

• Lead the major instrument related projects with functional areas to ensure all cGMP activities including qualification, validation and engineering activities are performed in accordance with the site analytical master plan.

• Collaborate with validation services, laboratory personnel and quality assurance to ensure alignment on priority for instrumentation activities, including qualification, validation, and retirement (decommissioning) activities.

• Manage oversite of initiation and completion of instrument related change controls, including execution of pre and post implementation requirements.

• Authors and facilitate the activities associated with documentation for instrument qualification and computer software/hardware validation protocols and final reports in conjunction with department subject matter experts and quality assurance.

• Leads management of the execution of qualification/validation activities for commissioning of new instrumentation.

• Ensure the completion of periodic reviews for both the computer system validation and instrument qualifications processes.

• Provide technical details to assist with the development of the 5-year instrumentation plan for the department.

• Develop and maintain an evolving comprehensive instrument and equipment inventory providing the laboratory instrument information and status.

• Maintain instruments in the Computerized Maintenance Management System (CMMS), including creation of service requests, and submission of work orders for repair.

• Manage facilitation of vendor-based activities to perform service including ensuring the performance of maintenance and calibration activities.

• Provide audit inspection responses, calibration failure investigations and instrument deficiency responses to support timely return to service.

• Lead inspectors/auditors through QC laboratory practices regarding laboratory instrumentation during internal and external audits.

• Execute process improvements of laboratory instrumentation within the Laboratory Execution System (LES) and other laboratory systems.

• Lead Quality Event deviations/investigation events through Root Cause Analysis as required.

• Lead the response to ensure that all data integrity requirements are being met within the laboratory with site functional teams.

• Lead and or present information at departmental or staff meetings.

Role Qualifications:

• Bachelors degree in Engineering with 5 - 7 years experience in the biopharmaceutical industry or MS degree with 4 years experience or equivalent combination of education and experience.

• Validation experience is a must (IQ/OQ/PQ)

• Experience authoring validation protocols

• Involvement with Commissioning/Decommissioning equipment

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

• Knowledge base of regulatory requirements for cGMP, computerized analytical systems, i.e., 21 CFR part 11, cGMP, data integrity, instrument life cycle, validation, disaster recovery and retirement preferred.

• Demonstrated leadership ability to lead projects within complex organization.

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

• Demonstrated problem solving ability, attention to detail, and analytical thinking skills.

• Interpersonal, oral, and written communication skills are essential.

• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility.

• Demonstrated ability to effectively lead in a multi-disciplined team environment to achieve goals.

• Ability to work independently.

• Contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.

• Demonstrate ability to effectively train and assist other less experienced.

BMSBL, VETERAN

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.

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