Associate Director, Equipment Commissioning and Qualification

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.

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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.

The Associate Director, Equipment Commissioning & Qualification Delivery supports the successful operation of facility, laboratory and manufacturing functions at a commercial cell therapy site through interaction with internal team members and peer‐level customers as well as external service providers.  The incumbent in this role supervises entry, junior, and experienced level professionals tasked with commissioning and qualifying new equipment, facilities, utilities and maintaining systems in a qualified / validated state according to established policies and procedures. The individual oversees multiple projects and ongoing work activities of low to high complexity to ensure on time and within budget completion. With expert knowledge of commissioning and qualification the individual will interact with regulatory agents, external and/or internal auditors in compliance audit environment.  The individual will advise ECQ personnel within their organization on career development and best practices.  As a key player for the organization, this position will closely collaborate with cross-functional stakeholders in a dynamic environment and can act as the backup for peers, managers, or direct reports and will be responsible for leading a commissioning and qualification team of ~20-30 employees, contingent workers and outside services.

Shifts Available:

Monday – Friday, Standard Working Hours

Responsibilities:

Direct and manage the CAR-T Equipment Commissioning and Qualification (ECQ) Delivery Team in support of the commercial manufacturing in the Summit West CAR-T facility. This includes:

• Hiring, mentoring, and developing exceptional people, conducting performance reviews, and identifying opportunities for career growth for Senior Managers, Managers, and Engineers
• Directly supervising 6-9 Senior Managers/Managers/Engineers
• Championing a culture of exceptional teamwork, accountability, continuous improvement, and communication across the organization and multiple sites within CTO
• Ensuring staff at all levels have and maintain the appropriate level of training necessary to support CAR T cGMP manufacturing in a multi-product commercial facility. Building effective cross-functional relationships with Manufacturing, Quality, Supply Chain, MS&T, EHS and Facilities
• Maintain departmental commissioning and qualification procedures and policies.  Ensure site and project qualification master plans comply with global policies and regulatory agency requirements
• Ensure resources performing qualification activities are knowledgeable of and in tune with latest industry regulations and initiatives
• Provide input and guidance for change strategy, risk assessment, testing and compliance gaps
• Ensuring a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements
• Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed
• Ensure compliance with Site Qualification Master Plan
• Departmental lead and SME in both internal and regulatory audits
• Ensuring safe, quality, and compliant o