Site Quality Head (Sr. Director), Vector Manufacturing Facility

Company: Bristol-Myers Squibb
Location: Libertyville
Posted on: November 13, 2024

Job Description:

Site Quality Head (Sr. Director), Vector Manufacturing Facility
Working with UsChallenging. 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.
Job Summary:
This role will be responsible for leading the day-to-day Quality operations at the Vector Manufacturing Facility including Quality Assurance Operations, Quality Systems, Compliance, and Quality Control. The role will also be a key contributor to the implementation and execution of BMS's quality systems in preparation for licensure/approval of this facility for use of the manufactured vector in BMS's Cell Therapy products. This includes but is not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure compliance of site operations to global GMP regulations. This individual will be a key leader in the Global Cell Therapy Vector Manufacturing Quality organization and a champion for quality principles and compliance within the Vector manufacturing Facility organization. This role is stationed at the Vector manufacturing facility at Libertyville, IL and reports to the Head, Cell Therapy Vector Quality in the US.
Job Responsibilities:

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• Responsible for the Quality oversight of GMP operations at the Vector manufacturing facility, and ensuring adherence to applicable GMP regulations and company policies and procedures.
  
• Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and manufactured vector.
  
• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management systems, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations.
  
• Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel.
  
• Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Patient Operations, MS&T, to ensure the timely facility qualification and readiness for licensure and approval of the facility.
  
• Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends.
  
• Lead the implementation of BMS's inspection readiness plan at the facility.
  
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the facility.
  
• Lead and host compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, etc.).
  
• Develop departmental goals and ensure timely completion of all deliverables.
  
• Champion and foster a positive and quality compliance culture.
  
• Establish and effectively manage site Quality's component of the Cell Therapy Quality annual operating budget.
  
• Represent and lead Cell Therapy Quality in the development of corporate initiatives and planning.
  
  Qualifications and Education Requirements:
  
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  • BS/MS/PhD in relevant Science or Engineering discipline and 15+ years of experience in Quality functions, and a minimum of 7 years of people management experience.
    
  • Expertise in GMP compliance and global (e.g., US, EU, JP) regulations.
    
  • Experience in hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers is required.
    
  • Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required.
    
  • Demonstrated Quality leadership through a partnership approach with manufacturing to enable high-quality and compliant product distribution to patients is required.
    
  • Background in Biologics or Cell Therapy Manufacturing is required.
    
  • Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams is required.
    
  • Strong technical knowledge, including practical problem-solving ability and work in highly metrics organization is required.
    
  • Experience in continuous improvement, operational excellence and Lean six-sigma is desired.
    
  • 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.
    
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Keywords: Bristol-Myers Squibb, Racine , Site Quality Head (Sr. Director), Vector Manufacturing Facility, Executive , Libertyville, Wisconsin