About BioMarin
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.
We will continue to focus on advancing therapies that are the first or best of their kind.
Our Technical Operations Group
The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Job Summary
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).
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
* CDMO oversight
* Lot disposition decisions
* Management of Quality Technical Agreements with external partners
Key Responsibilities
* Direct QA CDMO Operations team to provide quality oversight of Contract Manufacturing
* Oversight of the manufacture of multiple clinical products (Biologics, ATMP's Oligonucleotides and Small Molecules) ensuring adherence to GCP and GMP
* Establish and maintain procedures appropriate for use in clinical manufacturing in compliance with GCP and cGMP
* 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
Requirements
* Working knowledge of United States and European regulatory requirements, guidelines, and recommendations
* Working in clinical manufacturing is a plus
Additional Information
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.