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Site Quality Head
1 month ago
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.
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 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