Senior Manager, External QA Validation

Who We Are
Bio Marin 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 Bio Marin 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
Bio Marin’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 Bio Marin’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.

Manager/Sr. Manager, External QA Validation

The Manager/Sr. Manager, External QA Validation (Technical Quality) serves as a Quality technical lead for process validation and technology transfer activities across Bio Marin’s external manufacturing network, providing strategic Quality oversight of process validation, cleaning validation, equipment/facility qualification, and other validation activities supporting products manufactured at Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs).

This role is accountable for establishing and maintaining Quality expectations for validation and technology transfer, providing risk-based oversight throughout the transfer and validation lifecycle, and ensuring that external manufacturing processes and associated control strategies are appropriately qualified, validated, and maintained in accordance with Bio Marin standards and global regulatory expectations.

The role partners closely with Bio Marin’s Technical Development and Services (TDS), Global External Operations (GEO), External Quality Operations, Product Quality Leaders (PQL), and external partners to support successful technology transfers, validation readiness, commercial manufacturing and continuous improvements across the external network.

• Serve as the External Quality technical SME for validation and technology transfer, providing Quality leadership and oversight across Bio Marin’s external manufacturing network.
• Act as the Quality lead for technology transfers of manufacturing processes to CMOs/CDMOs, establishing effective Quality partnerships and supporting planned, predictable, and compliant transfer execution.
• Define and maintain Quality validation expectations and standards for externally manufactured products in alignment Bio Marin Global Policies, procedures, industry standards, and regulatory requirements.
• Provide Quality oversight of validation lifecycle activities, including process validation/PPQ, cleaning validation, equipment and facility qualification, and other GMP validation activities.
• Review and approve validation strategies, Validation Master Plans, protocols, reports, risk assessments, and other GMP documentation with the role’s accountability.
• Assess validation and technology transfer risks, identify gaps, recommend appropriate mitigation strategies, and elevate significant risks to Technology…