Director, QA Disposition

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.

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. Read more: careers.bms.com/working-with-us.

PURPOSE AND SCOPE OF POSITION: The Director of Quality Assurance Lot Disposition is a full-time position located at the BMS Cell Therapy Manufacturing Plant in Bothell, WA. The primary focus for this role is to lead the QA Lot Disposition team to ensure final drug products and raw materials are released to market following all BMS internal procedures and cGMP requirements. Included in the area of responsibilities is final drug product disposition, raw material disposition, lead the Cell Therapy Material Review Board (MRB), and Quality Master Data oversight. This person will be a key leader on of the site Quality Leadership Team and a champion for quality principles and compliance within the BMS Bothell organization. This position reports directly to the Head of Quality.

QUALIFICATION REQUIREMENTS:

• Bachelors or Masters degree in relevant Science or Engineering discipline
• 12+ years of experience in managing Quality functions; at minimum 8 years of people management experience. Or relevant combined education and industry experience.
• Background in commercial biologics is required with Cell Therapy Manufacturing experience preferred.
• Experience in both clinical and commercial GMP operations is preferred.

Key Knowledge, Skills, and Abilities

• Expertise in GMP compliance and FDA/EMA regulations.
• 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 experience working as a detailed oriented team player with effective planning, organization and execution skills.
• 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.

ROLES AND RESPONSIBILITIES:

• Ensure timely product disposition; manage the lot disposition activities for finished Cell Therapy drug products and raw materials by ensuring all relevant documentation associated with a lot are accounted for, completed and approved by the appropriate individuals.
• Collaborate with stakeholders and management and communicate lot disposition status; monitor progress and issue status reports.
• Lead Cell Therapy Material Review Board (MRB) meetings and evaluate recommendations made by the board during product disposition.
• Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
• Act as a key contributor to the BMS Cell Therapy lot disposition and MRB community of practice.
• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented cGMP policies and quality management systems.
• Develop departmental goals and ensure the timely completion of all deliverables.
• Champion and foster a positive and successful quality culture, aligned with BMS’ existing culture and values.
• Mentor Quality personnel and enable their individual growth.
• Interface and act as a subject matter expert for QA lot disposition oversight of cGMP operations during audits and regulatory inspections.
• Represent the Quality unit at various project meetings and provide quality input in the resolution of quality-related issues.
• Work to develop a high performing team delivering performance at a high degree of accuracy.

The starting compensation for this jo