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Sr. Associate QA Operations

Location Novato, California
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.

This position reports to the Manager, QA Operations and is responsible for quality oversight for processes relating to make, assess, and release at facilities in Novato.   

The responsibilities in the role include the following:

  • Provide Direct observation of Novato Make, Assess, Release (NMAR) operations for adherence to GMP. 
  • This includes direct coaching and mentoring of NMAR staff, real time review of documentation and observation of critical process steps. 
  • Coaching and development of junior QA staff on GMP standards and appropriate oversight of Operations activities.
  • Review of GMP documentation from manufacturing and QC, including log books, batch records and test records.
  • Review of SOP revisions initiated by manufacturing,QC, Facilities and Engineering.
  • Review and approval of quality system records including change requests, deviations and CAPA for NMAR Operations (i.e MFG, QC, FUE).
  • Preparation of manufacturing lots for manager review and disposition. 
  • Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations.
  • Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).
  • A B.S or B.A degree is required (scientific focus preferred)
  • 5 years of experience in biopharmaceutical manufacturing, QC or QA is required. 

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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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