Associate Director, ExM QA Lead

Location
Summit West, NJ, United States
Posted
Sep 16, 2020
Ref
R1528438
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.

The position provides Quality oversight for leading a team responsible for managing contract manufacturing organizations used for the bulk manufacture, packaging, testing and distribution of Clinical Supplies in accordance with corporate policies, procedures and GMPs. The incumbent will supervise a team and will report to the Director, External Manufacturing QA.

Duties and Responsibilities:

Oversees the Vendor Management System:
  • Monitor and provide guidance on the deployment of BMS requirements to qualify and maintain manufacturing facilities for the Manufacture, Packaging and testing of Clinical Products.
  • Ensures team is handling Complaints, Deviations, Testing, Stability and CAPAs in a compliant and timely manner.
  • Oversees the change management of externally manufactured BMS products are manufactured in full compliance with all applicable regulations.
  • Partners with SMEs to identify Quality and Compliance risks, discernable trends and develop / implement plans to mitigate via a risk management approach and management escalation.


Quality Review and Approval of GMP Documentation:
  • Performs other tasks as assigned.
  • Participates or supports Vendor Audits/Visits.
  • Final Quality approver for Quality Agreements, Vendor profile changes, audit schedule changes, documents for regulatory submission, etc.
  • Develop Quality metrics to monitor vendor quality systems are performing satisfactorily.


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 team and 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.
  • Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple IND/IMPDs through to successful NDA/MAH 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.

Education:
  • BS/MS in a Scientific discipline, preferably in Chemistry or Pharmacy.
  • 15+ years experience in relevant industry positions.
  • Hands-on CMC experience of clinical manufacturing across multiple modalities. Periods spent in Clinical manufacturing operations and prior people management would be considered advantageous.


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.

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.