Head of QA Technical Operations

Bristol Myers Squibb • Summit, NJ

20h

About The Position

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. 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. Summary The Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day quality review and approval of investigations, CAPA, Change Controls with associated documents and the oversight of the Quality Engineering team responsible for qualifications and validations of computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes. The Sr. Director, Quality Technical Operations will serve as a primary delegate and proxy for the Head of Quality, Cell Therapy Manufacturing at Summit, and is as a champion for quality principles and compliance within the organization.

Requirements

• Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
• Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise mindset) and makes the best decisions for the whole.
• Excellent influencing and negotiating experience and capabilities in a matrix environment.
• Must be able to interact with senior leaders as such is seen as a highly regarded and a credible leader with the ability to interface with stakeholders in a matrix environment.
• Proven track record of delivering results and is action oriented.
• Adapts to changing work environments, work priorities and organizational needs.
• Leads within the broader internal and external network and seeks to have impact on organization-wide performance.
• Embraces complexity but strives for simplicity.
• Shares resources and makes difficult trade-offs to benefit the organization at large.
• Creates a vision for the future by spotting strategic opportunities for breakthrough performance.
• Translates the case for change into actionable and strategic plans for the organization.
• Bachelor’s degree in relevant Science or Engineering discipline and 15+ years of experience in managing Quality Assurance function; at minimum 7 years of people management experience.
• Expertise in Good Manufacturing Practices (GMP) as related to Pharmaceutical, Biotech and/or ATMP Manufacturing.
• Experience with implementing and overseeing GMP operations in a plant manufacturing clinical and commercial products is required
• 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 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.
• Strong presentation and visual management capability required.
• Knowledge of performance measurement tools and metrics is required.
• Good facilitation, change management, interpersonal and problem-solving skills required.
• Experience with management of large teams, including direct and indirect reports, strongly preferred.

Nice To Haves

• Background in Biologics or Cell Therapy Manufacturing is preferred
• Expert-level expertise in one or more of the following: Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma strongly preferred

Responsibilities

• Responsible for QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification/validation at the Summit, NJ Cell Therapy manufacturing facility (S12).
• Drives for operational adherence to applicable cGMP regulations, BMS policies and procedures.
• Provides direction to Operations, Facilities, QC, and QA teams for planned and unplanned deviations to resolve compliance issues and procedural errors, ensuring immediate containment actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following any events.
• Strategically identifies, implements, and leads site-wide QA transformational programs and strategies in close partnership with Quality Systems, MS&T, Operations, Supply Chain and Quality Control to reduce Deviations, improve right first time, improve Quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.
• Ensures timely Quality support and approval of GMP documentation, risk assessments and change control impact assessments.
• Ensures the required processes, procedures, systems, and resources are in place to enable a compliant manufacturing of CAR T products.
• Maintains a comprehensive understanding of S12 manufacturing, QC testing processes and the associated risk management control strategy to identify process risks and associated critical controls around the associated processing steps.
• Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor through timely, positive, and constructive feedback and training.
• Serves as primary Delegate of Authority (DOA) and proxy for the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.
• Acts as subject matter expert for GMP operations during audits and regulatory inspections.
• Contributes to the development and execution of the S12 inspection readiness plan.
• Supports and facilitates Health Authority interactions, and ensures any regulatory observations are adequately addressed and completed on time.
• Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture, enhances employee satisfaction and retention, and drives a high-performing team.
• Provides leadership and builds an exceptional team to manage QA functions, including hiring, mentoring, and developing personnel.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Summit S12 facility
• Establishes and effectively manages the Summit Cell Therapy QA Technical Operations annual operating budget.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director