Sr. Technical Manager, Supplier Quality Management BPO

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.

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.

The Sr. Manager, QA, Supplier Quality Management BPO is an operational leadership role responsible for the execution, day‑to‑day management, and continuous improvement of core Supplier Quality Management (SQM) processes supporting Bio Marin’s external supply network for GMP/GDP materials. This role serves as the Business Process Owner (BPO) for the SQM quality process and is accountable for ensuring the processes are consistently applied, effectively monitored, and continuously enhanced across the global supplier base.

The Sr. Manager owns and executes the GMP/GDP material audit program, tracks and maintains key performance metrics for the Supplier Quality department and drives measurable continuous improvement initiatives. Additionally, this role leads the digitalization and AI enablement agenda for the department — translating strategic direction from the Director into practical implementation of automation, analytics, and AI‑enabled tools that improve efficiency, oversight, compliance and decision‑making.

The Sr. Manager also provides hands‑on support to the execution of Supplier Quality Category Manager activities, partnering closely with category managers, Procurement, and Technical Operations to ensure supplier qualification, quality agreements, changes, deviations, and performance activities are executed on time and to standard.

This position requires strong GxP execution expertise, disciplined process management, and the ability to operate effectively in a matrixed, cross‑functional environment with a focus on delivery, compliance, and operational excellence.

• Manage the end‑to‑end execution of the GMP/GDP material supplier audit program (outsourced), including annual audit planning, scheduling, execution oversight, follow‑up, CAPA tracking, and effectiveness verification.
• Ensure audits are completed on schedule in alignment with the approved audit plan.
• Coordinate internal and third‑party auditors, ensuring consistent audit standards, timely reporting, and closure of audit observations.
• Ensure supplier audit outcomes, identified risks, and corrective actions are appropriately documented, trended, and integrated into Supplier Lifecycle Management and Quality Management Review processes.
• Support and represent Supplier Quality during regulatory inspections and external audits involving suppliers, providing audit program data…