Senior Manager, Quality Control Investigations, Cell Therapy (R1552912-en-us)
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.
Bristol Myers Squibb is seeking a Senior Manager, QC Investigations for the Quality Control organization at the Cell Therapy Facility (CTF) in Devens, MA. This role is responsible for leading a team charged with performing QC high impact deviations, laboratory investigations, and CAPAs in accordance with BMS policies, standards, procedures and regulatory requirements. The Senior Manager will be responsible for hiring and developing a high performing team and will drive the QC Investigation and CAPA program performance, reporting metrics and continuous improvement progress. This role is stationed in Devens, MA and reports to the Associate Director of QC Systems.
• Hire, train, mentor and develop the team members to support the business operations and employee career development. Establish and communicate performance objectives that are consistent with company goals and objectives.
• Manage QC deviation and CAPA program, driving closure of QC high impact deviations, laboratory investigations, and CAPAs. Establish and maintain KPIs to ensure timely and compliant deviation and CAPA closure.
• Perform review of deviation and investigation reports, as well as review and approval of site and department SOPs related to investigations.
• Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment to enhance unit performance and integration across site departments.
• Collaborate with cross functional areas to develop training curricula related to investigations and provide training to new lead investigators.
• Contribute to and support the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
• Provide oversight to identify and implement changes that lead to realization of long-term department goals.
• Collaborate with other departments to identify and implement process improvements including the improvements identified through investigations.
• Communicate effectively with site leadership, department management and cross functional teams such as Manufacturing, QC Operations and QA. Present investigation findings and QC investigation program performance at Quality governance forums.
Qualifications & Education Requirements
• Experience in building and growing an organization into a high performing team.
• Strong background and demonstrated effectiveness in laboratory or biomanufacturing investigations and root cause analysis techniques.
• Knowledge of cell therapy analytical and microbiological testing is highly desirable.
• Knowledge of US and EU cGMP regulations and health authority inspections.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.
• Must be action-oriented and skilled in decision-making, problem solving, conflict management, planning and organizing, resource allocation.
• Bachelor’s degree in science, engineering, or related discipline. Advanced degree preferred.
10+ years of experience in biopharmaceutical or QC lab operations with 4+ years of prior management experience required. An equivalent combination of education and experience may substitute.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
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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