Executive Director, Global External Quality
BioMarin Pharmaceutical Inc.About the role
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.
About Technical Operations
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.
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 innovative 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.Job SummaryThe Global Head of External Quality is responsible for leading the quality strategy, oversight, and compliance of the company’s global external manufacturing network, including CMOs, CDMOs, contract laboratories, and other GMP-relevant third parties.This role provides end-to-end quality oversight for externally manufactured small molecule, large molecule/biologic, and finished drug products supporting both commercial and clinical supply across multiple markets. The position ensures outsourced operations are compliant with global regulatory requirements, internal quality standards, and patient safety expectations.The Global Head of External Quality partners cross-functionally with Technical Operations, Supply Chain, Regulatory Affairs, Procurement, MS&T, Clinical Supply, and Commercial Quality to ensure external partners operate in a state of control, support uninterrupted supply, and maintain inspection readiness. This position will sit on the Global Quality Leadership Team (GQ-LT) and Global External Operations Leadership Team (GEO-LT). The Global Head of External Quality is accountable for ensuring that external manufacturing partners consistently operate in a state of control and compliance, and that outsourced manufacturing activities reliably deliver products that meet required standards for identity, strength, quality, purity, safety, and efficacy. The role is also accountable for protecting the organization from quality, compliance, and supply risks arising from the external network, while enabling the business to scale globally with confidence.The incumbent will hire, train, develop and retain a highly skilled quality, compliance, and analytically savvy workforce; driving excellence in Quality; effectively implementing new quality guidance’s where necessary, and create an environment where our people will be engaged, grow, and thrive displaying a strong quality culture.ScopeThe Global Head of External Quality is responsible for leading the quality strategy, oversight, and compliance of the company’s global external manufacturing network, inclu
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