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Director, Material Review Board and Disposition
3 months ago
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
This role is responsible for leading the Material Review Board (MRB) and the Disposition groups at the Summit Cell Therapy S12 site. Responsibilities include but not are not limited to the oversight of the cross functional Material Review Board meetings at S-12 ensuring all related actions and follow ups to the meetings are completed timely. The incumbent will be responsible for all quality activities associated with the final disposition / release of product as well as improving and maintaining systems related to lot release needs, communicating those needs, and driving organizational changes to improve time to release.
**Shift Available**:
- Monday - Friday, Hybrid role
**Responsibilities**:
- Accountable for the effective and efficient execution of the MRB and disposition processes in full compliance with all internal and external regulatory requirements.
- Sets the mission, strategy, goals, objectives, and KPIs for the teams.
- Ensuring teams remain flexible and agile to respond to changing business needs by promoting cross-training between teams.
- Assures standard operating procedures (SOPs) related to the team's job responsibilities define the steps necessary to complete tasks in an efficient and compliant manner.
- Accountable for any global, regulatory, or corporate inquiries related to the MRB and disposition processes.
- Supports site and functional teams during regulatory inspections or audits, which may include direct interaction with inspectors/auditors as well as writing and/or reviewing responses.
- Manages departmental operational expenses in alignment with allocated budget.
- Strong supporter of Culture of Excellence across CTDO and adherence to BMS core behaviors.
- Provide leadership and support for systems project teams, site initiatives, and committees to ensure that all system issues and opportunities are addressed in a timely, effective, and First-Time manner.
**Knowledge & Skills**:
- Understanding of technical areas related to pharmaceutical, biological, and/or cell therapy manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes, validation and qualification requirements, etc.
- The position requires strong capabilities associated with organizing workload and tracking progress of multiple deliverables tied to multiple batches pending release simultaneously.
- Experience leading continuous improvement and operational excellence transformations within Quality Operations.
- Demonstrated Quality leadership and a partnership approach with Operations to enable high-quality and compliant product distribution to patients.
- Experience managing regulatory audits or regulatory inquiries.
- Demonstrated influential leadership expertise and experience with senior and mid-level management. Ability to partner and influence site leadership functional areas inside and outside of Quality Operations.
- Demonstrated enterprise mindset with an ability to think and act across functions and divisions.
- Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve objectives, and to effectively communicate challenging goals and objectives.
- Demonstrated strong leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.
- Demonstrated agility in anticipating and leading others through change and ambiguity.
- Ability to provide innovative ideas or alternatives that create value, including seeking new information and external insights without compromising compliance.
- Excellent teamwork, interpersonal, and communication skills, with the ability to establish direction, create an atmosphere of trust, an
