QA 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.
The Quality Assurance Systems Associate is responsible for maintaining and continuous improvement of site quality systems, providing quality oversight of the facility.
The position requires thorough knowledge and experience with EU & FDA GMP regulations as well as developed organizational, and project management skills.
- Participate in activities related to core quality systems
- Deviations, Change Controls and CAPA’s
- Document Control
- Internal Audit
- Inspection Readiness
- 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.
- 5+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
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.