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Job Summary

Bristol Myers Squibb is seeking a Director of Quality Assurance at the Vector Manufacturing facility in Libertyville, Illinois (USA). This role will be responsible to provide senior leadership to the Libertyville Quality organization and oversee the QA Shop Floor, Quality Engineering and QA Operations organizations for the Vector Manufacturing Facility.

The Director of Quality Assurance Operations will be a key member of the facility’s Quality Leadership Team and a champion for quality principles and compliance within the Libertyville organization.
This role is stationed in Libertyville, Illinois and reports to the Senior Director of Quality for the Vector manufacturing Facility.

Job Responsibilities

• Directs the quality oversight of operating procedures for the facility’s 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 facility’s CTO quality assurance program which assures effective floor quality presence in the facility’s 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 of the Manufacturing, Supply Chain, and Quality Control organizations for the facility during the facility licensure period.

• Provides leadership to cross-functional team(s) responsible for supporting Quality Engineering-related activities (e.g., commissioning, qualification, validation) as well as investigating deviations during vector manufacturing and testing.

• Participates in the site 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 business 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 personnel have adequate training, education and experience to perform their GMP related job function effectively.

• Leads complaint and other above-site 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 site’s Investigation Review Board.

• Participates as Quality Representative or liaison for facility-related projects, as applicable

• 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.

• 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-performing 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 EU and US cGMP regulations and guidance.

• Extensive and proven experience in FDA (or other major regulatory authority) Preapproval Inspection preparation and management is essential.

• Demonstrated leadership, interpersonal, communication, and motivation skills.

• Knowledge of applicable business systems such as: SAP, LIMS, Maximo and Veeva.

• Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable

BMSCART

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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