Head of QA CDMO Operations, External Quality

The Head of QA CDMO Operations is a highly motivated technically knowledgeable leader with proven abilities to direct quality assurance activities across multiple external business partners for Technical Operations (TOPS). The successful candidate will strengthen the Quality culture and ensure the manufactured product intended for Clinical Trials meets all company standards and government regulations. This leader will develop a high performing team and provides leadership and guidance to the organization. By providing strategic direction, setting clear expectations, goals and metrics, the leader is accountable for quality activities related to all clinical phases of production generated at our Contract Development and Manufacturing Sites. These products span different platforms including biologics, devices, gene therapies, oligonucleotides, and small molecules. The leader would champion continuous improvement to reduce variability in production and to maintain high quality product.

This position requires a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. Accountabilities include CDMO oversight, lot disposition decisions, and management of Quality Technical Agreements with external parties. The Head of QA CDMO Operations will build strong Quality to Quality relationships with Technical Development and with Contract Development & Manufacturing Organization (CDMO) sites, to ensure effective communications and oversight of CDMO operations. The incumbent is expected to work with cross functionally to resolve issues, improve relevant business processes and systems.

The Head of QA CDMO Operations will report to the Executive Director Global Quality, External Manufacturing and Supply, and is responsible for, Contract Development & Manufacturing Organization Quality Assurance, and release to the clinic. This position will sit on the External Quality Leadership Team.

Travel of 20-25% may be required.

SCOPE

People Leader, with a team of ~5 people, in multiple global locations and time zones, all working to make quality product for patients in clinical trials.

The Responsibilities In The Role Include The Following

Direct QA CDMO Operations team to provide quality oversight of Contract Manufacturing, and supporting operations including, but not limited to:

• Oversight of the manufacture of multiple clinical products (Biologics, ATMP’s Oligonucleotides and Small Molecules) ensuring adherence to GCP and GMP.
• Ensure appropriate oversight and documentation from manufacturing, QC, and Technical Development
• Establish and maintain procedures appropriate for use in clinical manufacturing in compliance with GCP and cGMP.
• Review of SOPs, master batch records, or any other documentation to assure successful manufacture of product.
• Review and approval of quality system records including change requests, deviations, and CAPA as necessary.
• Review and Disposition of finished goods or other manufactured product.
• Partner with Technical Development and Clinical Supply Chain to ensure delivery of compliant material to patients.
• Provide strategic direction to the QA CDMO Operations department to ensure that corporate objectives are met, including improving internal processes and practices.
• Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations. Working in clinical manufacturing is a plus.
• QA representation during site health authority inspections, and business forums including MRB and site leadership teams.
• Ensure QA staff training and development.
  
  
  

This position will interact with other departments throughout the organization. This position will partner with and influence Quality, Technical Development, Regulatory Affairs, Compliance, Finance, MSAT, and other departments as required. This position requires constant contact with Senior Management across the organization.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.