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

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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 not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure the 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 individual will be a member of the Site Leadership Team. 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:

• 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 system, 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:

• 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 require