Senior Technical Manager, Quality Compliance
3 weeks ago
Senior Technical Manager, Quality Compliance - Novato, California
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.
About the role
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.
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BioMarin Pharmaceutical is open for
The story
Our culture revolves around the ethos that no disease should go untreated, and our people are driven to discover, develop, and commercialize medicines that give patients, their families, and their caregivers hope where there was little or none.
There are
1001+
employees in the company
500M+
500M+
Company annual revenue
Product
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.
The company's product portfolio comprises three approved products and multiple clinical and pre-clinical product candidates.
Approved products include Naglazyme (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany.
Offices
The company's office is headquartered in US with additional offices located in Ireland, UK, Netherlands, Brazil, Hong Kong and Japan.
San Rafael
Dublin
London
Hong Kong
Tokyo
Team events
Learn more about BioMarin Pharmaceutical
BioMarin Pharmaceutical serves clients from United States, United Kingdom, Brazil, Netherlands, Japan, Ireland.
Senior Technical Manager, Quality Compliance - Novato, ... - BioMarin Pharmaceutical - Novato, US
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Senior Technical Manager, Quality Compliance
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Novato, California, United States BioMarin Pharmaceutical Inc. Full timeWho 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...
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