Job Description:
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 provide 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.
Key Accountabilities:
* CDMO oversight
* Lot disposition decisions
* Management of Quality Technical Agreements with external partners
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 ensuring the manufactured product meets company standards and government regulations, developing a high-performing team, and providing leadership and guidance to the organization.
Scope:
The responsibilities in this role include:
* Directing QA CDMO Operations team to provide quality oversight of Contract Manufacturing
* Oversight of manufacture of multiple clinical products (Biologics, ATMP's Oligonucleotides and Small Molecules) ensuring adherence to GCP and GMP
* Ensuring appropriate documentation from manufacturing, QC, and Technical Development
* Establishing and maintaining procedures for use in clinical manufacturing in compliance with GCP and cGMP
* Review and approval of quality system records, change requests, deviations, and CAPA as necessary
* Review and disposition of finished goods or other manufactured product
* Partnering with Technical Development and Clinical Supply Chain to ensure delivery of compliant material to patients
Requirements:
* Working knowledge of United States and European regulatory requirements, guidelines, and recommendations
* Experience working in clinical manufacturing is a plus
* QA representation during site health authority inspections, and business forums including MRB and site leadership teams