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Job Details


Bristol Myers Squibb

Manager, Quality Assurance Shop Floor Cell Therapy

Technology

Quality Assurance

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.

The Manager of QA Shop Floor is responsible for providing management for the QA shop floor program in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Responsible for managing the activities of the shop floor team to ensure manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.

12 hours shift with split week including one weekend day

Wed-Sat 5pm-5:30am every other Wed off

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Must have GMP, Quality, and in-depth risk management knowledge.

  • Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.

  • Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.

  • Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.

  • Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.

  • Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholder’s cross-functionally.

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

  • Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.

  • Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.

  • Routinely recognizes and resolves Quality issues; Informs upper management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.

  • Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.

  • Scope of problem solving includes direct reports. Critically assesses project(s) and allocates resources to efficiently achieve goals. Implements solutions independently. Develops employees.

  • Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.

  • Manages conflict and issues with internal and external customers. Demonstrates negotiation skills in internal and external cross-functional teams. Demonstrates coaching skills.

Education and Experience:

  • Relevant college or university degree required.

  • Minimum 7 years relevant Quality Assurance experience, 3 years in an aseptic environment and minimum 3 years of leadership experience.

  • Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

  • Supervise and manage the QA shop floor program and group located at the Summit S12, NJ facility.

  • Provide leadership and build an exceptional team to manage the QA shop floor program, including hiring, mentoring, and developing personnel.

  • Ensure manufacturing compliance with applicable procedures and batch records.

  • Perform real time review of manufacturing batch records.

  • Review manufacturing shop floor documentation.

  • Issue production batch records and product labels to Operations.

  • Ensures control of systems, processes and product through supporting review and approval of change notices and change control.

  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

  • Must be skilled in planning and organizing, decision-making, and building relationships.

  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

  • Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.

  • Updates and procures approval of job descriptions for department personnel. Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages, and motivates staff. Writes and administers performance appraisals for department personnel.

  • Able to effectively multi-task.

WORKING CONDITIONS (US Only):

Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used. Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

BMSCART, VETERAN, #LI-Onsite

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.

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