Technical Quality Assurance Manager

2 weeks ago

Novato, California, United States Biomarin Full time
About Us


At BioMarin, our Technical Operations team is dedicated to the development and production of our innovative therapies for clinical trials and commercial distribution.

Our skilled engineers, technicians, scientists, and support personnel are committed to establishing and maintaining BioMarin's advanced manufacturing processes and facilities. They ensure quality assurance and quality control measures are upheld to meet regulatory requirements, while also managing the procurement of essential goods and services to facilitate manufacturing and oversee the global distribution of our therapies to patients.


BioMarin is a pioneer in providing therapeutics that significantly improve the lives of patients facing serious and life-threatening rare genetic disorders. We focus on conditions that lack effective treatments and impact relatively small patient populations, many of whom are children. These diseases are often hereditary, challenging to diagnose, progressively debilitating, and have limited or no treatment options. BioMarin remains committed to advancing therapies that are either the first or the best available. Join our team to make a meaningful difference in the lives of patients.
Position Overview

The Quality Systems Technical Manager plays a crucial role in ensuring that BioMarin's Quality Systems—including Documentation, Deviation, CAPA, Change Control, Self-Inspection, and Risk Management—are effectively implemented and adhered to.


Key Responsibilities:
  • Engage in inspection readiness, support during regulatory inspections, and conduct self-inspection activities.
  • Analyze quality system metrics and trends.
  • Collaborate cross-functionally with management within and outside of Technical Operations to promote uniformity in the application of quality systems.
  • Contribute to quality system enhancements and process mapping initiatives.
  • Draft and manage site Quality Technical Agreements.

Qualifications:
  • Bachelor's or Master's degree, preferably in life sciences.
  • A minimum of 6 years of experience in the pharmaceutical or related industry.
  • Proven knowledge of cGMPs, Health Authority Regulations, Quality Systems, and technical proficiency in manufacturing processes.
  • Ability to understand technical information related to analytical methods, manufacturing processes, and regulatory expectations.
  • Familiarity with FDA, European, and international regulatory standards.

Equal Opportunity Statement:

BioMarin is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Compensation:

The salary range for this position is competitive and will reflect internal equity, geographic region, job-related knowledge, skills, and experience among other factors. Additional compensation may include a discretionary bonus and/or long-term incentive units, along with a comprehensive benefits package.

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