Description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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.

Role Overview

The Associate Director, External Quality Control (Technical Quality) serves as the QC technical authority within External Quality Operations, providing strategic and scientific oversight of QC activities performed across Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), and Contract Testing Organizations (CTOs).

This role is accountable for defining analytical strategy, method lifecycle expectations, and QC performance standards across the external testing network, ensuring data integrity, regulatory compliance, and inspection readiness.

Key Responsibilities

• Serve as the authoritative QC SME for analytical methods, specifications, and QC data supporting external manufacturing.
• Define QC technical requirements and performance expectations for external laboratories.
• Lead risk-based assessments of QC capabilities across CMOs/CTOs/CDMOs, including analytical technologies, method lifecycle maturity, and data integrity practices.
• Ensure external QC activities are aligned with regulatory expectations and internal quality standards.
• Provide Quality oversight for analytical method lifecycle activities including validation, verification, transfer, and lifecycle management at external sites.
• Lead or oversee method transfer strategies and execution readiness, ensuring robustness and comparability across sites.
• Partner with Analytical Sciences (e.g., APTL/APL) to support method lifecycle management, continuous improvement, and issue resolution.
• Ensure consistency of analytical methods and documentation across external sites in alignment with internal and regulatory standards.
• Establish and maintain QC performance monitoring frameworks across external laboratories.
• Lead statistical trending and analysis of QC metrics and signals, including, system suitability performance, invalid assay rates, method variability and drift
• Utilize data to identify emerging risks, drive continuous improvement, and inform oversight strategies.
• Author and review QC sections of regulatory submissions (e.g., BLA, MAA, IND), ensuring scientific integrity and consistency.
• Support health authority inspections and responses, including defense of analytical methods and data.
• Ensure alignment of external QC practices with global regulatory expectations (FDA, EMA, ICH).
• Represent External QC in cross-functional governance forums, including QC Network Strategy (QCNS), Analytical/Quality Partner Teams (APT/QPT)
• Provide input into external laboratory selection, make vs. buy decisions, analytical control strategies
• Provide technical SME leadership for QC-related investigations, including OOS/OOT and method performance issues.
• Lead or support root cause analysis and define technically sound corrective actions.
• Partner with internal QC and Analytical Sciences teams to ensure appropriate qualification, lifecycle management, and use of reference standards and critical reagents at external laboratories.
• Provide QC SME support during audits and inspections, ensuring technical practices are consistent with QMS requirements.
• Experience leading cross-functional teams and influencing technical decisions without direct authority.
• Other duties as assigned.
• Periodic travel is required.

Experience/Education

• PhD with 4+ years, MS with 6+ years, or BS with 8–10+ years in analytical sciences, Quality Control, or related discipline.
• Significant experience in cGMP-regulated biopharmaceutical environments.
• Demonstrated expertise in analytical method lifecycle management, validation, comparability, regulatory submissions (BLA/MAA/IND), and Health authority interactions.
• Strong understanding of global regulatory requirements including FDA, EMA, ICH, WHO, and Health Authority inspection expectations.
• Demonstrated knowledge of Data Integrity principles (ALCOA+).
• Experience supporting regulatory inspections, audits, and health authority interactions.
• Deep expertise in analytical techniques used for biologics/small molecules (e.g., chromatography, bioassays).
• Experience in statistical analysis and trending of QC data preferred.
• Experience with external manufacturing/testing networks (CMOs/CDMOs/CTOs) strongly preferred.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.