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Job Details


Bristol Myers Squibb

Manger, Supplier Quality

Technology

Quality Assurance

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.

Position

Manager (EG-110), Supplier Quality

Manager

Associate Director (EG-140), QA Engineering

Prerequisites (As Applicable)

B.S. degree required, 4-7 years of experience in the pharmaceutical or related industry.

Location

Summit, New Jersey

PURPOSE AND SCOPE OF POSITION:

This position provides quality oversight for material suppliers and vendors used to manufacture, package and test BMS clinical and commercial cell therapy products in accordance with policies, standards, procedures and international cGMP’s. The incumbent will be responsible for the approval activities related to various suppliers including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, package and testing of CAR-T products. To the latter, the incumbent will also have additional responsibilities that include but are not limited to, providing quality support to internal BMS stakeholders and SMEs, reviewing/ approving product related GMP documents, authoring supplier quality system documents.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

  • Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
  • Knowledge of cell therapy manufacturing processes and testing is preferred.
  • Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes
  • Experience with performing/participating in risk assessment exercises.
  • Experience in Supplier Quality oversight.
  • Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR.
  • Excellent investigational and QA problem solving skills – e.g.
    • Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
  • 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 have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
  • Analytical mindset – e.g.
    • Able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures; able to identify acceptable mitigation actions.
    • Able to recognize quality risks and develop contingency plans.
    • Able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors. Able to author resulting procedures and tools.
    • Able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally.
  • Quality performance / continuous improvement oriented – e.g.
    • Able to create and maintain meaningful metrics for assigned activities.
    • Able to recognize trends in product data and results.
    • Able to assess and recommend improvement measures to processes; able to drive implementation accordingly.
  • Good understanding of batch disposition principles, aligned with QP concept and associated duties including liaison with Health Authorities.
  • Skilled in planning and organizing, building relationships, innovation management and resource allocation.
  • Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
  • Team spirit. Action-oriented and customer-focused.
  • Negotiation and persuasion skills.
  • Good knowledge of most common office software (Microsoft Office).
  • Good verbal and written communication skills in English a must.

DUTIES AND RESPONSIBILITIES

QA lead on technology transfer activities (process transfers, analytical and microbiological method qualifications and/or transfers):

  • Ensure transfer plans, transfer/qualification protocols, associated reports, procedures, master batch records, methods, material specifications, risk assessments, protocol discrepancies and new product introduction change controls are compliant with internal standards and/or regulatory requirements, as applicable.
  • Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
  • Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
  • Interact and collaborate with cross-functional teams to achieve common goals.
  • Provide training to QA colleagues on new product manufacturing process and analytical methods, as applicable to ensure clinical production readiness.

Support Product/Program Lifecycle Management Activities

  • Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
  • Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
  • Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
  • Review media simulation activities to ensure successful execution and documentation.
  • Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
  • Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
  • Ensure procedures are adequate to review and confirm appropriateness of data.

Display Leadership Qualities

  • Create an environment of teamwork, open communication, and a sense of urgency
  • Promote a mindset of continuous improvement, problem solving, and prevention
  • Drive strong collaboration within the site and across the network
  • Build trust and effective relationships with peers and stakeholders
  • Drive improvements to remove inefficiencies, improve quality and optimize productivity.
    • Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.

EDUCATION AND EXPERIENCE (As Applicable)

  • B.S. degree required.
  • 4 to 7 years in the pharmaceutical or related industry.
  • Equivalent combination of education and experience acceptable.

WORKING CONDITIONS: (US Only)

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.

This is the end of the Official Use document

REVISION HISTORY

Effective Date

Version

Change Description

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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.