Bristol Myers Squibb Company

R1528485 Manager, External Manufacturing QA (Open)

Location
Summit West, NJ, United States
Posted
Sep 10, 2020
Ref
R1528701
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.

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.

The position provides Quality oversight for the selection of contract manufacturing organizations used for the manufacture, packaging, testing and distribution of Clinical Supplies in accordance with Celgene policies, procedures and GMPs. The incumbent will cover multiple products at the Contract Service Provider (CSPs) and will report to the Associate Director, External QA Lead.

Duties and Responsibilities:
  • Oversees the Vendor Quality Management Systems:
    • Partner with Technical Operations to identify and qualify manufacturing facilities for the Manufacture, Packaging and testing of Clinical Products.
    • Serves as the Celgene Quality single point of contact for the assigned CSPs with responsibility for Quality and Compliance performance.
    • Ensures Complaints, Deviations, Stability and CAPAs are managed in a compliant and timely manner.
    • Oversees vendor change control process and ensures that Celgene products are manufactured in full compliance with all applicable regulations.
    • Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status.
    • Partners with Technical Operations to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
  • Quality Review and Approval of GMP Documentation:
    • Develop Quality metrics as part of a balanced scorecard to assess ongoing monthly performance.
    • Final Quality approver for all GMP documentation associated with Batch Records, Investigation Protocols etc.
    • Responsible for final Batch Disposition decisions.
    • Participates in Celgene Corporate Vendor Audits.
    • Perform other tasks as assigned.


Skills/Knowledge Required:
  • Must have expert 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 drive development of technical or scientific initiatives 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 stakeholders 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. Must possess authenticity.
  • Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful NDA approval.
  • Good understanding of the GMPs as related to Clinical Manufacturing.
  • Understanding of Health Authority expectations relative to CMC Development as well as Clinical Trial supplies.
  • Knowledge of required QP processes for Investigational Materials and expectations for International markets.
  • Good Knowledge of CMC Regulatory affairs.
  • Hands-on CMC experience of clinical manufacturing. Periods spent in Clinical manufacturing operations would be considered advantageous.


Education:
  • BS/MS in a Scientific discipline, preferably in Chemistry or Pharmacy. 10 years experience in relevant Pharmaceutical industry and role.


Working Conditions:

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.

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.