Bristol Myers Squibb Company

Sr Manager Quality Compliance Cell Therapy

Location
Celgene, NJ, United States
Posted
Aug 24, 2020
Ref
R1527667
Required Education
Bachelors Degree
Position Type
Full time
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.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PURPOSE AND SCOPE OF POSITION:

This is an individual contributor position

The Sr Manager Quality Compliance is responsible for management of Global Cell Therapy compliance activities for Quality in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMPs. Functional responsibilities for the incumbent include ownership of the Global Cell Therapy Material Review Board process and Biological Product Deviation Reports process, ownership of the Cell Therapy Global Recall/Investigational Withdrawal process and coordination of the Cell Therapy Tier 2 Quality Council, management of corporate audits for Global Cell Therapy functions, management of the inspection readiness program for Global Cell Therapy functions, management of emerging regulations and systematic evaluation of new requirements.

The Quality Systems organization is responsible for the establishment, maintenance and continuous improvement of compliant Quality Management Systems (QMS) to ensure processes, procedures, and responsibilities meet quality policies and objectives. This organization supports Global Cell Therapy and the corporate functions in Seattle and Summit to coordinate and direct activities to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

● Extensive knowledge of US and global cGMP requirements, and ability to use judgment and this knowledge to determine appropriate quality systems compliance for site. Preferred experience with ATMP Regulations.

● Must have a comprehensive understanding of Good Manufacturing Practices (GMP) regulations and guidance (ICH, CFR, PIC/S, EU, etc.) as related to pharmaceutical and biotechnology manufacturing

● Experience in Recall/Investigational Withdrawal Management.

● Experience facilitating Quality Council/Management Review with senior management.
  • Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally
  • Must be able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc.

● Experience in independently drafting field alert notifications and/or Biological Product Deviation Reports for the FDA or the equivalent notifications to other health authorities globally

  • Experience in hosting and facilitating internal audits/Health Authority inspections.


● Ability to make independent and objective decisions and to work with minimal supervision

● Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and team members with clarity, brevity, and accuracy

● Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Must possess authenticity
  • Working knowledge of core quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
  • Demonstrated project management skills with a proactive approach to issue identification and resolution
  • Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact
  • Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met
  • Excellent verbal and written communication skills
  • Required to travel approximately 25% of time


Education and Experience:
  • BS required, advanced degree preferred.
  • Minimum 8+ years experience in the pharmaceutical industry is required.
  • Thorough understanding of cGMPs and FDA regulatory requirements.
  • Experience leading internal audits and health authority inspections.
  • Work independently, yet effectively in a team environment.
  • Strong attention to detail, excellent verbal and written communication skills.
  • Excellent investigational and QA problem solving skills.


DUTIES AND RESPONSIBILITIES:
  • Develop, implement and oversee the Global Cell Therapy Material Review Board, Biological Product Deviation Report, Investigational Withdrawal, and Recall programs in alignment with BMS policy to support the continued oversight and assurance of product quality and compliance
    • Develop and implement applicable procedures and work practices
    • Develop, implement and monitor applicable GMP/GDP quality and compliance KPIs; implement processes for addressing identified trends.
  • Serve as the primary point of Contact for the Quality Council program across Cell Therapy.
    • Own the Cell Therapy Global Quality Management Review program.
    • Work with sites to implement standardized site level Quality Management Review
    • Liaise with Global Quality Team to ensure appropriate escalation to BMS Global Quality Council
    • Responsible for compilation of metrics and information flow across Quality Councils
  • Manage or support health authority inspections, internal audits and diligence teams as a subject matter expert
  • Work in close collaboration with the manufacturing site Compliance functions to ensure consistency in compliance approach, initiatives
  • Lead the implementation of compliance activities across the corporate functions of Cell Therapy by guiding teams on accurate and timely responses to risks
  • Lead compliance and continuous improvement projects across the Cell Therapy Network
  • Other responsibilities as assigned by management
  • Travel - 25%


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 30%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.

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.