(CW) Technical Manager, QA (Contract)

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.

 Contract -Hybrid Role - 3 days in the office in Novato, CA


SUMMARY DESCRIPTION:

Responsible for owning and continuously improving one or more global Supplier Quality Management
(SQM) processes at BioMarin. As Business Process Owner (BPO), they are accountable
for the overall efficiency/effectiveness of the Supplier Change Notification (SCN)
process and Approved Supplier List (ASL) process at BioMarin. The Technical Manager
will be accountable for developing, executing associated processes, programs, and
initiatives to ensure overall supplier performance for GMP Material Suppliers to support
BioMarin’s Drug Substance and Drug Product manufacturing. They will contribute to the
implementation of a risk-based approach to the management of SCNs and lead efforts for
periodic review and updates. They will establish the governance structure and controls to
ensure the SCN and ASL processes are consistently applied across the supply base,
ensure the health of the SQM process is continuously evaluated, and drive continuous
improvement.
Cross functional collaboration with external and internal partners and stakeholders across
different sites and functions is key for success in this role. This includes collaboration
with Supply Chain, Compliance, Global Sourcing and Procurement (GSP), Global
Manufacturing Sciences and Technology (GMSAT), and other site functions.
This position requires knowledge and experience with supplier management processes.
The person must possess technical expertise and business acumen in the areas of
responsibility.

RESPONSIBILITIES
▪ Lead Quality-related reviews, cross-functional process teams, serving as a subject
matter expert for Supplier Change Notifications.
▪ Lead all quality aspects for the management of BioMarin’s Approved Supplier
List.
▪ Establish process to monitor SCNs through key performance indicators (KPIs),
trend analysis, and regular reviews, identifying and leading opportunities for
improvement.
▪ Serve as the Business Process Owner for SCN and ASL process(es), proactively
monitoring and maintaining the health of the process and subprocesses, driving
continuous improvement efforts, and sustaining compliance with current and
evolving global health authority requirements and regulations.
▪ Review and approve Supplier Change Notifications in the QMS.
▪ Make decisions and act with authority to carry out actions as applicable.
▪ Collaborate with external/internal global and site stakeholders to identify, define,
and implement opportunities for improved SCN process workflows, while
aligning the process with organizational goals and strategies. Promote knowledge
sharing and the best practices.
▪ Develop, implement, and communicate quality policies and procedures to ensure
consistency across the network and alignment with global processes.
▪ Support implementation of program enhancements to SCN and ASL processes.