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Senior Technical Manager, Quality Compliance (MQR) - Novato, CA

BioMarin Pharmaceutical Inc.
Novato, California
Start date
May 20, 2024

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Who We Are

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.

Senior Technical Manager, Novato Quality Compliance (MQR) SUMMARY The Senior Technical Manager is part of the Novato Quality Compliance group reporting to the Head of Compliance.  The role is responsible and accountable for establishing and maintaining Novato’s Manufacturing Quality Management System Review as well as establishing and executing site Annual Product Review (APR) programs.   This position will be responsible for establishing Manufacturing Quality Review (MQR) process and system that assesses Novato manufacturing quality management system performance, effectiveness and adequacy and identify opportunities for improvement. The Senior Technical Manager is also responsible for establishing and maintaining Annual Product Reviews (APRs) for all products manufactured at the Novato Site (PPQ to commercial). The MQR and APRs together provide critical information on the performance and effectiveness of our QMS and Products health.  This role requires close cross-functional collaborations to drive activities that will ensure a state of continuous GMP compliance in Novato and identify for opportunities for improvements.  This position requires critical thinking ability, high level of influencing, collaboration, leadership courage as well as a broad range of knowledge and experience with biologic and chemical processes, and in-depth knowledge of GMP compliance across various drug manufacturing stages.   KEY RESPONSIBILITIES  -Establish Novato site specific APR process and procedures. -Ensure Novato APR is executed according to procedures. -Author Novato site APR.  Collaborate with stakeholders to identify, escalate, and resolve issues.  -Establish and maintain Novato’s MQR process and systems. -Effectively collaborate with Global Quality Assurance ensuring alignment with QSMR process and expectations -Effectively collaborate with Product Quality Life Cycle Management group in establishing Novato APR Process ensuring alignment. -Establish and maintain community of practice with other BioMarin Sites to benchmark, improve and standardize (as needed) across the network. -Interact with senior level leadership teams in Novato and across the network to escalate significant issues or obtain sponsorship of initiatives for MQR and APR processes. -Define and implement systems, and metrics. -Benchmark leading practices within our peers in the industry and implement improvements. -Work closely with the compliance team to close gaps and improve inspection readiness capabilities. -Provide training on APR and MQR as needed. -Support regulatory inspections.  Experience: -10+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry -7+ years experience in quality/compliance, MSAT or other technical areas.  -Demonstrated strong knowledge of Global pharmaceutical/biotechnology industry regulations, and GMPs as well as BioMarin’s and guidance documents. Ability to interpret standards for implementation and review requited. -Strong Knowledge of analytical and manufacturing data required. -Demonstrated knowledge, application and use of statistics, data acquisitions, visual management tools, and other technology platforms. -Excellent interpersonal and communication skills (written & verbal) and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally and at all levels. -Demonstrated ability to partner with other functional group to achieve business objectives. -Demonstrated ability to work effectively in a matrix environment and drive results through influencing to resolve complex technical, quality, and business-related issues.   -Demonstrated ability to drive continuous improvement and operating with a Lean and Agile mindset. -Consistent demonstration of leadership courage  -Results oriented; effectively manages multiple projects efficiently. -In-depth understanding and application of cGMP principles, concepts, practices, and standards   Education: -This role requires being on site and 5 days/week. -Ability to travel domestically and internationally up to 30%   Other: Ability to travel up to 30%  

Equal Opportunity Employer/Veterans/Disabled

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.


BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

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