Job Description

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.

About BMS

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immuno-science and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Senior Manager, Vector Vendor Quality Management (VQM)

Responsibilities

* Develop supplier qualification practices that use risk-based tools for assessments, qualification and performance monitoring that consider KPI development/tracking and operational deliverables.
* Develops and implements policies and procedures for Contract Manufacturing Organization (CMO) and Contract Test Lab (CTL) compliance; including development of Quality Agreements, Quality Business Processes, Product Disposition and Quality Event Resolution (Deviations, OOS, CAPA, Change Control)
* Ensures approved quality systems are established and maintained to BMS quality standards and regulatory requirements.
* Partner closely with BMS External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners.
* Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.
* Effectively communicatee issues, risks and proposed solutions within the organization.
* Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.
* Provide communication, support, and guidance to manufacturing partners and within the QA Vector team.
* Serves as a Quality subject matter expert on Vector and Cell Bank related production teams.
* Perform batch record review and lot disposition activities as required
* Support internal and external audits as needed, including PLI/PAI preparations.
* Other duties as assigned.
* Up to 25% travel.

Qualifications

* Bachelors degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas.
* Experience managing external suppliers and supply chain-related issues.
* Experience and understanding of Quality Control processes and laboratory practices to enable understanding and assessment of quality issues related to contract test labs.
* 15+ years related industry experience with a minimum of 5 years experience in quality assurance, quality control, and compliance.
* Strong organizational skills, including ability to follow assignments through to completion.
* Advanced skills in leading, influencing, negotiating, and supplier management.
* Independent decision-making capability and ability to think strategically and understand global impact of decisions.
* Excellent verbal and written communication skills.
* Proven leadership and mentoring skills for junior staff.
* Proven ability to work effectively in a matrixed organization
* Advanced knowledge of relevant regulations and guidance for Cell Therapy products. Able to act as a resource for colleagues.
* Audit and inspection management experience.
* Ability to prioritize and successfully manage complex and competing projects.
* Detail-oriented with expertise in problem solving and solid decision making abilities.

Preferred Qualifications

* Experience with Cellular Therapeutics and/or gene based products.
* Knowledge of Quality Control including but not limited to familiarity with analytical methods and controls, stability, and process controls.
* Experience with product launch including PLI/PAI.
* Experience with Commercial products manufacture, supply and post-approval change management.
* Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.
* Experience in a fast-paced matrixed environment

If you want to challenge yourself, accelerate your career, and give new hope to patients, theres 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.

BMSCART

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.