Senior Manager, Quality Assurance Material Operations, Cell Therapy
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:
The Senior Manager, Quality Assurance Material Operations, Cell Therapy role is responsible for the development, implementation, execution, and sustainability of quality and material disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP.
This individual will lead a team responsible for oversight and performance of the incoming material visual inspection, disposition, and eSystem master data programs. The individual will ensure timely and accurate delivery of disposition requirements from stakeholder groups such as Quality Control and supply chain. This individual will ensure compliant release of incoming raw materials and consumables, maintenance, and review of SOPs, and acts as a Subject Matter Expert in projects and regulatory inspections.
Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. This role will work with Supply Chain, Manufacturing, Quality Control, Digital Plant, Supplier Quality and other local and global stakeholder groups.
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.
- Completes routine tasks with little or no supervision and moderate complexity tasks with input as needed from quality leadership.
- Confident in making decisions and problem solving for minor to moderate issues.
- Routinely recognizes Quality issues and opportunities for efficiency.
- 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.
- Able to prepare written and verbal communications and convey problems to management with clarity and accuracy.
- Able to effectively multi-task.
- Knowledge of US and global cGMP requirements.
DUTIES AND RESPONSIBILITIES
- Responsible for oversight and implementation of the incoming material inspection and disposition programs
- Responsible for the oversight and implementation of highly complex and integrated eSystem quality master data approvals in ERP and electronic Batch Record systems (SAP and Syncade MES respectively).
- Hire, train, and coach a mix of single contributor and first line people leaders to execute the book of work and sustain programs.
- Represent the Devens facility in network initiatives for harmonization and at community of practices
- Responsible for material control philosophy and oversight for the site
- Present and review the programs with internal, global, and health authority auditors.
- Approve Cohort to Material and other SAP/MES master data elements to support quality assurance
- Maintain quality Inspection Plans in SAP to align with procedural requirements for disposition activities.
- Oversee and approve all procedural documentation for incoming material programs.
- Approve new material requests for the site
- Interface with global Material Planning, Supply Chain, and Supplier Quality teams as Devens site representative.
- Perform impact assessments and own Quality System records for the incoming and master data programs.
EDUCATION AND EXPERIENCE
- A minimum of 8 years of experience in the pharmaceutical or related GMP industry.
- A Bachelor’s degree in a biological science, engineering, or similar. An equivalent combination of education, military service, and experience will be considered.
WORKING CONDITIONS: (US Only)
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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