Quality Systems Associate
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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s 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. Come join our team and make a meaningful impact on patients’ lives.
Annual Product Review
Site Master File
Oversee relevant metrics and trending for each quality system and take action to drive the correct behaviours.
Manage the preparation and facilitation of Corporate & Regulatory Inspections.
Use science and risk based methods to increase Quality Culture throughout the facility.
Provide Root Cause Analysis support for the site
Maintaining the core Quality Systems, and providing training on the core Quality Systems
Leading internal audits for the site
Development and Trending of Quality metrics for the site to ensure continuous improvement of Quality Systems and Manufacturing processes
Liaise with Novato colleagues to aid in harmonization of Global Quality functions and systems
Drive projects to improve Quality Systems across site
Liaise with Regulatory department to support GMP filings as required
B.S. with at least 5 years of experience in a relevant functional area.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.