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Senior Technical Manager, Quality Compliance - Novato, California

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

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Job Details

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 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 self-inspection program for all GMP areas including clinical manufacturing and testing areas including network services that are managed out of the Novato site.   This position will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Novato and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in compliance. The Sr. Technical Manager will also provide support during regulatory inspections.   This position requires critical thinking, high level of influencing, collaboration, leadership courage as well as a broad range of knowledge and experience with biologic and chemical processes, in-depth knowledge of GMP compliance across various drug manufacturing stages, self-inspection principles as well as managing and interacting with health authorities during inspections.   KEY RESPONSIBILITIES  -Establish and maintain an effective self-inspection program for the Novato site that is inclusive of all GMP activities to continuously increase our GMP compliance state and facilitate constant inspection readiness.  Effectively collaborate with Novato Leadership Team (NLT) to obtain endorsement and sponsorship of the program. -Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends. -Effectively collaborate with Global GMP audit team -Establish and maintain community of practice with other BioMarin Sites to benchmark, improve and standardize (as needed) across the network. -Define and implement systems, and metrics for maintaining regulatory compliance for all operations. -Perform evaluations of GMP compliance across all site areas and procedures and processes. -Benchmark leading practices within our peers in the industry and implement improvements. -Identify trends in recent regulatory inspections and translate this to the self-inspection program to improve readiness. -Work closely with the compliance team to close gaps and improve inspection readiness capabilities. -Responsible for Novato Site GMP training program, training material content generation and requirements. -Knowledgeable in current industry compliance and inspection trends.   -Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives.  Experience: -10+ years of experience with Biotechnology, Pharmaceutical, Medical Device or Other highly regulated industry -5+ years experience with leading/hosting regulatory inspections, managing inspection readiness programs, self-audit programs and inspection response process required. Experience in Quality, Compliance and MSAT preferred. -Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally. -Demonstrated ability to partner with other functional groups to achieve business objectives. -Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management. -Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships with minimal resources. -Consistent demonstration of leadership courage  -Ability to influence diverse stakeholders and drive accountability and decision-making cross-functionally. -Results oriented; effectively manages multiple projects efficiently. -Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker. -In-depth understanding and application of cGMP principles, concepts, practices, and standards -Regulatory, Quality, Compliance, or a combination of technical experience such as analytical development/manufacturing sciences and Quality/Regulatory. -Proficiency in data analysis and visual management tools   Education: -BA/BS in life sciences or related field -Advance degree desirable, but not required.  Other: -This role requires being on site and 5 days/week. -Ability to travel domestically and internationally 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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United States

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