Manager, Incoming Material Inspection and Disposition, 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 Quality Assurance Incoming Material Inspection and Disposition Manager is responsible for supervising quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. The role will oversee the routine and timely release of incoming materials such as consumables, raw materials, and viral vector in compliance with all applicable regulations and guidelines.
Functional responsibilities include performing material release within the inventory management system (SAP), ensuring accurate and timely maintenance and review of batch related documentation, oversight of incoming material visual inspection, and close coordination and planning with Supply Chain. This individual will also be responsible for maintenance and review of SOPs, and act as a Subject Matter Expert in product disposition.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
- 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.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little supervision.
- Confident in making decisions for minor issues.
- Routinely recognizes Quality issues and solves problems.
- Is recognized Subject Matter Expert within the group.
- Capable of providing input within the department and cross functional teams.
- Builds relationships internally within and with cross functional teams.
- 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.
- Excellent verbal and written communication skills.
DUTIES AND RESPONSIBILITIES:
- Develops and maintains Standard Operating Procedures, training, and business processes supporting incoming material disposition and visual inspection of incoming materials.
- Supervises and performs the execution of routine material disposition activities by ensuring all relevant documentation associated is accounted for, completed, and approved under GMP standards.
- Verify accuracy and acceptability of documentation, such as Certificate of Analysis or deviation reports, to support material disposition.
- Provides coaching, training, and professional development to their team members to develop their skills and create an environment of continuous learning, improvement, and innovation.
- Contributes to and supports the site team which prepares for, hosts, and responds to Health Authority inspection reviews and approvals of the facility and products
- Performs review of deviations related to incoming material.
- Perform required updates to lot status in applicable quality systems. Ensure lot disposition status is monitored and communicated to appropriate stakeholders.
- Hires, coaches, and develops a team to support the incoming material disposition and visual inspection process.
- Develops process improvement strategies and supports execution of site/team continuous improvement goals and projects.
- Participates and supports internal and external audit activities as needed,
- Provides guidance to less experienced staff with atypical events during day-to-day operations
EDUCATION AND EXPERIENCE:
- Minimum of 6 years of pharmaceutical experience or related GMP industry. Previous quality experience is preferred.
- A Bachelor’s degree in a biological science, engineering, supply chain, or similar or an equivalent combination of education, military service, and experience.
Work in a cGMP manufacturing environment following techniques which require one to maintain a high attention to detail. Properly use Personal Protective Equipment (PPE), gowning for controlled areas, and work in a general office environment.
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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