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Manager - Incoming Quality Assurance Disposition Cell Therapy

Company: Bristol Myers Squibb
Location: Devens
Posted on: June 1, 2021

Job Description:

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 Manager, Incoming Quality Assurance Disposition position will support the startup of the BMS Devens Cell Therapy Facility (CTF) by developing the procedures and business processing for all incoming materials including raw materials, consumables, and other starting materials. The role will oversee the routine incoming and on-time release of materials to support manufacturing. This individual will also be the SAP Subject Matter Expert (SME) for the Disposition organization.

PURPOSE AND SCOPE OF POSITION:

This role is responsible for quality and incoming material disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures and Global cGMP. Functional responsibilities include performing incoming material release, ensuring accurate and timely maintenance and review of incoming and/or kitting documentation, and providing operations shop floor oversight. This individual will ensure accurate and timely release of raw materials, consumables, and other incoming components, maintenance and review of SOPs, and acts as a Subject Matter Expert in incoming material disposition.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
  • Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Must possess an independent mindset and tenacity.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little supervision.
  • Work is self-directed.
  • Confident in making decisions for minor issues.
  • Routinely recognizes Quality issues and solves problems.
  • Is recognized Subject Matter Expert within the group.
  • Provides guidance to other employees in interpretation of complex data.
  • Capable of providing input within the department and cross functional teams.
  • Builds relationships internally within and with cross functional teams.
  • Contributes to goals within the work group.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
  • Excellent verbal and written communication skills.
  • Strong Knowledge and User of SAP Required.
  • Education and Experience:

B.S. degree required, minimum 6 years of experience in the pharmaceutical or related GMP industry required, of which 2 years is within Quality Assurance

  • DUTIES AND RESPONSIBILITIES:

  • Contribute to the start up of the Devens cell therapy facility, including procedure and business process development for the incoming material disposition process
  • Responsible for disposition of incoming production materials.
  • May support release activities for site manufactured drug product.
  • Review and approval of incoming documentation.
  • Provide oversight of QA shop floor program.
  • Issue production batch records and product labels or Operations as needed.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations and CAPA management.
  • Coordinate with global and other cell therapy site functions for alignment

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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Keywords: Bristol Myers Squibb, Nashua , Manager - Incoming Quality Assurance Disposition Cell Therapy, Other , Devens, New Hampshire

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