Senior Technical Manager, Supplier Quality Management

Who We Are

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.

SUMMARY DESCRIPTION The Senior Technical Manager, Supplier Quality Management (SQM) will be responsible for owning and ensuring the quality and compliance of a category of supplier’s within BioMarin’s global supplier network.  Emphasis will be on Single Use Technologies (SUTs) such as Filters, Bioprocess Containers, Reusable Tubing Assemblies, and some Consumables used in BioMarin’s Drug Substance and Drug Product manufacturing.  The Senior Technical Manager will be accountable for developing, executing associated processes, programs, and initiatives to ensure and improve overall supplier performance for GMP Material Suppliers. They will design and contribute to the implementation of a risk-based supplier quality management program and lead efforts for periodic review and updates.  They will establish the governance structure and controls to ensure the SQM process is 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, Global Sourcing and Procurement (GSP), Global Manufacturing Sciences and Technology (GMSAT), and other site QA functions.   This position requires in depth knowledge and experience with supplier management and supplier qualification.  The leader must possess strong leadership qualities, business acumen and technical expertise in the areas of responsibility. RESPONSIBILITIES-Lead Quality-related reviews, cross-functional process teams, and highly complex supplier investigations/CAPAs, serving as a subject matter expert for assigned supplier category.
-Lead all quality aspects for the selection, onboarding, and approval of suppliers.
-Implement risk-based approaches to identify, assess and mitigate supplier related risks, ensuring the continuity of supply and the quality of materials.
-Develop, establish, and maintain Quality Technical Agreements with global suppliers to define quality expectations and responsibilities.
-Establish process to monitor supplier performance through key performance indicators (KPIs), trend analysis, and regular reviews, identifying and leading opportunities for improvement.
-Serve as the Business Process Owner for one or more SQM (Supplier Quality Management) process(es), proactively monitoring and maintaining the health of the process and subprocesses, driving continuous improvement efforts globally, and sustaining compliance with current and evolving global health authority requirements and regulations.
-Make decisions and act with authority to carry out actions as applicable.
-Develop and maintain strong relationships.  Collaborate with external/internal global and site stakeholders to identify, define, and implement opportunities for improved SQM process workflows, while aligning SQM 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. 
-Lead and/or support implementation of program enhancement and strategic SQM projects internally and at suppliers.
-As needed, partner with Compliance on qualification and surveillance of supplier audits.  
-Provide SME support to site inspections, global inspections, and related observation responses.
EDUCATION
-BA/BS/Ph. D in life sciences or related field
-Advanced degree desirable, but not required. EXPERIENCE-8+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
-Extensive knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
-Prior experience and knowledge in Supplier Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. Knowledge in international regulatory landscape preferred.
-Experience in Supplier Management; Combination Products/Device Quality desirable.
-Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management