Associate Director, Field Quality Assurance

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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

PURPOSE AND SCOPE OF POSITION:

This role is responsible for the day-to-day operations of the Field Quality Assurance (QA) team at the Devens, MA Cell Therapy Manufacturing site. The Field QA team is responsible for 24x7 oversight of the operations at the Devens site, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.

This person will be a key leader in the Quality Assurance management team and a champion for quality principles and compliance within the Quality organization. This position reports directly to the Director of Cell Therapy Quality Assurance for the Devens site.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Expertise in GMP compliance and FDA/EMA regulations

• Experience with implementing and overseeing GMP operations in a plant manufacturing commercial products

• Background in Protein Biologics or Cell Therapy Manufacturing is desired

• Demonstrated experience building and leading exceptional teams is required

• Demonstrated excellence in written and verbal communication

• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships

• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment

DUTIES AND RESPONSIBILITIES

• Responsible for the Quality Assurance oversight of GMP operations at the Devens Manufacturing site and ensuring adherence to applicable GMP regulations and BMS policies and procedures

• Provide direction and ensure timely guidance to Field QA personnel during handling and resolution of GMP events (deviations, non-conformances and corrective action assessments)

• Develop a comprehensive understanding of the manufacturing processes followed for BMS products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.

• Collaborate with stakeholders and management, and effectively communicate status

• Ensure timely Quality support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs

• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management system

• Contribute to the development and execution of BMS Inspection readiness plan at the Devens Manufacturing site

• Develop departmental goals and ensure the timely completion of all deliverables, including batch record review

• Champion and foster a positive and successful quality culture, aligned with BMS’s existing culture

• Mentor Quality personnel and enable their individual growth

• Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections.

EDUCATION AND EXPERIENCE

• BS/MS in relevant Science or Engineering discipline and 9+ years of experience in within a GMP Quality Assurance function (or equivalent experience) with a minimum of 7 years of people management experience

WORKING CONDITIONS: PHYSICAL /MENTAL DEMANDS:

• Able to stand and walk for several hours at a time to provide on-the-floor leadership and GMP walkthroughs

• Able to move between rooms in a timely manner.

• Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).

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.

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.

#BMSCART, #VETERAN, #LI-Onsite

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.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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