Job Title: Head of QA CDMO Operations
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
About the Role:
* Direct quality assurance activities across multiple external business partners for Technical Operations (TOPS)
* Strengthen the Quality culture and ensure manufactured products meet all company standards and government regulations
* Develop a high-performing team and provide leadership and guidance to the organization
* Set clear expectations, goals, and metrics for quality activities related to all clinical phases of production generated at our Contract Development and Manufacturing Sites
About You:
* Broad range of knowledge and experience with biologic processes, drug development, analytical testing methods, and international regulatory landscape
* CDMO oversight, lot disposition decisions, and management of Quality Technical Agreements with external partners
* Strong Quality to Quality relationships with Technical Development and Contract Development & Manufacturing Organization (CDMO) sites
Responsibilities:
* Direct QA CDMO Operations team to provide quality oversight of Contract Manufacturing
* Oversight of manufacture of multiple clinical products ensuring adherence to GCP and GMP
* Establish and maintain procedures appropriate for use in clinical manufacturing in compliance with GCP and cGMP
* Review of SOPs, master batch records, or other documentation to assure successful manufacture of product
* Review and approval of quality system records including change requests, deviations, and CAPA as necessary
Requirements:
* People leader with a team of ~5 people in multiple global locations and time zones
* Working knowledge of United States and European regulatory requirements, guidelines, and recommendations
* Working in clinical manufacturing is a plus