Sr. Specialist, Quality Control Laboratory Compliance

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.

Bristol-Myers Squibb in Summit, NJ is searching for a remarkable Sr. Specialist, QC Laboratory Compliance to join our amazing team. As our Sr. Specialist, QC Lab Compliance you will be responsible for developing and maintaining various programs and systems to ensure harmonization, compliance and quality for all QC laboratory testing teams. The Sr. Specialist will be expected to become an SME for various laboratory processes. This position involves performing lab walk-throughs, GEMBA walks, leading process improvement projects across QC.

This Position qualifies for a $10,000 Sign-on Bonus, $5,000 payable within 30 days of start date and $5,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only

Role Responsibilities:

• Collaborate with Quality Control, Manufacturing, Quality Assurance, and Equipment, Commissioning and Qualification (ECQ).

• Initiate deviations and lead and perform complex investigations.

• Drive audit readiness of GMP laboratories.

• Use Quality Systems to support response to deviations, audit findings and process improvements.

• Ensure harmonized processes are in place across QC and support migration to electronic systems.

• Collaborate with area management to prioritize and lead continuous improvement initiatives.

• Compile specific metrics to be included into the QC trending reports.

• Participate in project teams while managing timelines, resources, and communication specific to the individual tasks.

• Interact and collaborate with departments (on and offsite) as well as vendors, consultants, and other external service providers.

Role Requirements:

• Bachelors’ degree required. An equivalent combination of education, experience and training will be considered.

• 5 years of relevant work experience required, preferably in a regulatory industry.

• Advanced verbal and written communication skills with the ability to tailor communication style for a wide variety of audiences.

• Ability to collaborate cross functionally to drive operational and quality excellence.

• Advanced organizational and time management skills.

• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.

• Advanced teamwork and facilitation skills.

• Knowledge of Lean Six Sigma principles and ability to lead a project.

• Requires strategic thinking and ability to work independently.

• Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.

• Ability to interpret and author general, technical, and complex business documents.

• Advanced knowledge and implementation of data integrity principles.

• Ability to represent the department in regulatory inspections.

• Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.

• Proficiency in MS Office applications, with special emphasis on Excel. Proficiency in administering computer-based programs.

BMSCART, 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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