Bristol Myers Squibb Company

Senior Manager, Supplier Quality Cell Therapy

Location
Celgene, NJ, United States
Posted
Sep 13, 2020
Ref
R1527628
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.

PURPOSE AND SCOPE OF POSITION:

This position provides quality oversight for material suppliers and vendors used to manufacture, package and testBristol Myers Squibb (BMS)clinical and commercial cell therapy products in accordance withBMS 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 toBMS 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 a must.


EDUCATION AND EXPERIENCE:
  • BS or MS or equivalent education in Science, or related fields required.
  • Minimum 5-8 years of experience in a pharmaceutical/ biopharmaceutical environment including previous QA experience - e.g. QA compliance role, Supplier Quality oversight


DUTIES AND RESPONSIBILITIES:

The position holder is responsible and accountable for the tasks given below (non-exhaustive list):
  • Quality oversight of the activities and services provided by suppliers - e.g.
    • Serves as the site single point of QA contact for suppliers for cell therapy program.
    • Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities.
    • Initiate and Manager Supplier Quality risk assessments.
    • Create / negotiate and maintain Supplier Quality Agreements.
    • Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of Deviations, Complaint investigations and CAPAs; ensures properly documented perBMS procedures.
    • Evaluate and communicate supplier quality related changes, ensuring assessment perBMS change control procedures and documented in a timely fashion.
    • Collect APR-PQR related information and data perBMS requirements.
    • Participate inBMS audits at suppliers, as needed. Travel could be up to 25%.
    • Coordinate / Support the Supplier Quality Review Board to promote discussions surrounding Supplier Quality Vendor Changes and Supplier Issue, as well as the approval process for new suppliers.
    • Measure supplier quality performance, periodically collect and share quality performance metrics. Identify potential trends, working closely with supplier to define possible areas for improvement and associated implementation plan.
    • Collect supplier quality documentation necessary to support regulatory submissions.
    • Hold appropriate periodic quality meetings with supplier representatives, as needed.
    • Hold or actively participate in joint periodic meetings with stakeholders.
  • Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system - e.g. support and quality guidance to record owners, follow up until completion, owner role as appropriate, closure in a timely manner.
  • Partner with stakeholders to assess overall supplier performance, including identifying product-specific quality and compliance risks and develop mitigation plans based on a risk-based approach.
  • Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.
  • Act as representation for Quality Operations as required, escalate critical issues to Management as appropriate.
  • Author necessary quality system documents; review and update procedures for BMS Quality Management System per process ownerships.
  • Support Health Authority inspections and audits of the site, act as QA representative (SME) for functional area relevant topics.
  • Participate as QA representative to internal work streams, projects and improvement initiatives.


WORKING CONDITIONS (US Only):
  • The incumbent will be required to work in office environments
  • The incumbent may be required to enter controlled areas and supporting areas
  • The incumbent (or designee) will be expected to support CTDO of all related Supplier Quality activities off-shift if needed
  • Occasional travel may be required


BMSCART

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.