Bristol Myers Squibb Director, Cell Therapy Quality Assurance in Devens, Massachusetts
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 Director of Quality Assurance at the Cell Therapy Facility (CTF) in Devens, MA. This role will be responsible to provide senior leadership to the Devens Quality organization and oversee the QA Field, QA Investigations and Quality Engineering organizations.
The Director of Quality Assurance will be a key member of the CTF Quality Leadership Team and a champion for quality principles and compliance within the Devens Cell Therapy organization.
This role is stationed in Devens, MA and reports to the Executive Director of Quality for the Devens Cell Therapy Facility.
Directs the quality oversight of operating procedures for the CTF quality assurance program of investigation and resolution of deviations, CAPA, the Cell Therapy change control program and validation programs.
Directs the quality oversight of operating procedures for the Devens CTO quality assurance program which assures effective floor quality presence in the Cell Therapy Facility (CTF) Manufacturing and Warehousing operations
Directs the quality oversight of start-up and lifecycle activities including approval of batch recipes, testing methods and associated process, and laboratory technical documentation.
Directs the QA support for ongoing validation activities for equipment, cleaning, sterilization, and process qualification and validation.
Directs the QA support of the Manufacturing, Supply Chain, Site Engineering, Digital Plant, Manufacturing Sciences and Technology and Quality Control organizations for the Cell Therapy Facility.
Provides leadership to cross-functional team responsible for investigating deviations during Cell Therapy manufacturing and testing.
Participates in the Cell Therapy team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
Defines departmental roles and accountabilities and, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.
Establish and communicates performance objectives for staff that are consistent with the businesses unit goals, as well as Quality objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent.
Ensures that all QA personnel have adequate training, education and experience to perform their GMP related job function effectively.
Leads BPDR investigations, as required.
Provides Quality oversight towards the resolution of product and process issues associated to Quality Events.
Provides Quality oversight in Technology Transfer initiatives.
Leads the CTF Investigation Review Board.
Participates as Quality Representative or liaison for CTF projects.
Supports Process / Manufacturing decisions during audits with regulatory agencies.
Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.
Approves Corrective and Preventative actions (CAPA’s).
Serves as a Quality liaison with internal and external customers.
Reviews and approves procedures related to process, products, utilities, and laboratories.
Prepares site Key Performance and trending metrics.
Verifies compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications.
Qualifications and Education Requirements
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required
A minimum of 10 years experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility.
Experience in building and growing an organization into a high performance team.
Strong background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with direct accountability for investigations and change control programs.
Knowledge of cell therapy, biologics manufacturing or analytical testing is highly desirable.
Extensive knowledge of US and EU cGMP regulations and guidance.
Extensive and proven experience in FDA (or other regulatory authority) Preapproval Inspection preparation and management is essential.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva.
Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable
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 email@example.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1557874
Updated: 2022-05-28 02:08:15.291 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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