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Bristol Myers Squibb

Senior Manager, Quality Control Compliance, 2nd Shift Wed-Sat (R1556052-en-us)

Technology

Development Manager

Yearly

No

Summit, New Jersey, United States

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 looking for a remarkable Sr. Manager, QC Compliance to join our growing team! As our QC Compliance Sr Manager, you will manage the general operation and workflow of all of the S12 QC related compliance records across Deviations, CAPA's and Change Control. You will also work closely with the Lab Excellence team and provides insight into areas for improvements. This role will also manage and motivate team members, build trust, and cultivate a collaborative environment. Oversee team responsibilities and maintain a state of compliance.

This position is part of the Summit Quality Performance and Improvement Organization, which is comprised of three pillars: Compliance, Continuous Improvement, and Governance / Project Management. While this is a site-based role, collaboration across other sites in the CTDO network and the BMS Global network is essential.

Role Responsibilities:

  • Provide analysis of opportunities for operational improvement in the Quality Control department for Deviations, Corrective and Preventative Actions and Change Control relative to CTDO and Summit - S12 goals.

  • Form project teams and champion the execution of agreed projects using project management, problem-solving and operational excellence tools.

  • Collaborate with other Site and network Operational Excellence team members to ensure initiatives external to the S12 site can be leveraged to obtain intended benefit of those external initiatives.

  • Mentor direct reports in problem-solving, professional growth and operational excellence.

  • Identify and implement KPIs or other appropriate metrics (as needed) to monitor progress and benefit of projects and initiatives.

  • Develop and implement (as needed) standard operating procedures, work practices and guidance’s.

  • Under the guidance of Senior Leadership support special project work.

  • Author non routine Protocols in support of projects.

  • Initiate and perform Deviation Investigations/CAPA’s associated with Quality Control Analytical and Microbiological testing.

  • Interface with Regulatory Agency Inspectors/Auditors.

  • Working independently, carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

  • Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives, emerging as a leader.

  • Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications.

  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times, and have a deep understanding of USP, EP, JP, and FDA microbiology testing requirements.

  • Identify and execute Continuous Improvement Projects for the department. Lead and develop best practices in the laboratory.

  • Using technical expertise troubleshoot and solve problems that may come up in the day-to-day operation of the department.

Role Requirements:

  • Requires Bachelor’s degree in Microbiology, Biotechnology, Molecular Biology, or related discipline. An equivalent combination of experience/education will be considered.

  • 12 years of experience working in microbiology in a pharmaceutical manufacturing environment with team leadership experience.

  • Must have expert GMP, Quality, and in-depth risk management knowledge, particularly in cGMP Quality Control.

  • Must be able to interact with and influence multidiscipline departments and CTDO sites

  • Must be able to effectively prepare reports with high level of precision, communicate data analysis to management and others within group with clarity and accuracy and provide guidance to others in technical interpretation of data

  • Must have experience in root cause analysis and proven track of implementing corrective/preventative actions commensurate with level of Quality and Compliance Risk

  • Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking

  • Must be skilled in coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation

  • Must possess an independent mindset and tenacity

  • Communicate effectively with peers, department management and cross-functional peers and Management.

  • Capable of leading local cross-functional and Global teams, as required.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.