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Bristol Myers Squibb

Manager II, Quality Investigations S12 MSAT (R1558989-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.

PURPOSE AND SCOPE OF POSITION:

The Manager II is responsible for leading and oversight of deviation records, ensuring Quality and Compliance of investigation reports, in support of S12 CAR T operations. This role is responsible for directly managing personnel dedicated to investigations of deviating events. The individual filling this role can interface with multiple groups, independently perform tasks, interpret results, author reports, grow and develop a team. Additionally, this Manager II is responsible for continuous compliance improvements within the Deviation Management Program. The Manager II will ensure all deviation records are closed in a timely manner. Deviation investigation includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, overseeing/authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. The successful incumbent must interface closely with different functional organizations and management, including Quality Assurance teams.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Advanced working experience of deviation investigations utilizing root cause analysis tools.
  • Working experience in the CAPA process and ability to identify and verify effectiveness.
  • Advanced technical writing skills, and capability to review, improve, and approve investigation reports from more junior team members
  • Capability to kickoff and lead limited duration investigation teams, to ensure timely completion of more complex investigations requiring scientific work outside of S12 site
  • Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
  • Experience supporting health authority inspections. The Manager II role will often defend more complex investigation reports in Regulatory Investigator questioning during Health Authority audits.
  • Knowledge of data trending and tracking, including use of statistical analysis software a plus.
  • Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
  • Ability to set priorities, manage timelines and effectively react/manage changing priorities.
  • Ability to work with management (global and site) and support corporate and departmental goals.
  • Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.
  • Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
  • Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control. Proven delivery of complex investigation reports is required for the Manager II role.
  • Ability to train and mentor junior associates to foster and develop their expertise.

Education and Experience:

  • Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
  • Minimum 5+ years of relevant work experience, preferably in a health authority regulated environment.
  • A minimum of 3+ years of leadership (people management) experience or mentorship of junior associates.
  • Manager II Level requires capability in medium and high-risk deviation reports or equivalent proven experience.
  • Previous experiences working in a biopharmaceutical manufacturing facility and an aseptic environment is preferred (CAR T a plus).
  • An equivalent combination of education and experience may substitute.

DUTIES AND RESPONSIBILITIES:

  • Oversee or able to conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
  • Attend deviation triage meetings and assign/schedule deviations records to investigators.
  • Oversee medium and high-risk investigation teams with the ability to summarize progress to Sr. Management, collect information from the triage team, and gather necessary supporting data from technical and quality teams outside of S12.
  • Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause analysis.
  • Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
  • Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
  • May Initiate change control documentation.
  • Identify functional area SMEs to perform impact assessments as part of the change management process.
  • Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
  • Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
  • Lead deviation investigation defense during audits and site inspections.
  • Handle complex issues and solve problems with minimal guidance. Manage teams to support more complex investigations.
  • Manage personnel dedicated to investigations of deviating events.
  • Set measurable and quantifiable yearly goals and Objectives. Perform Annual Performance Reviews against established pre-established objectives.
  • Ability to identify performance deficiencies and create measurable Performance Improvement Plans (PIPs).
  • Serve as author or technical reviewer of departmental procedures as appropriate.
  • Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
  • Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset.

WORKING CONDITIONS (US Only):

  • The incumbent will be working 80% to 90% of the time in an office environment.
  • The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
  • The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
  • The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.

#LI-Onsite

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.

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