Supplier Quality Management Process Manager

Supplier Quality Management Process Manager

Hybrid – 3 Days Onsite in Novato, CA

12-Month Contract

Summary

Our client, a leading biotechnology company, is seeking a Supplier Quality Management Process Manager to oversee and continuously improve global Supplier Quality Management (SQM) processes. This role will serve as the Business Process Owner for Supplier Change Notifications (SCN) and the Approved Supplier List (ASL), ensuring supplier quality, regulatory compliance, and consistent process execution across the organization. The ideal candidate will bring strong experience in supplier quality, GMP-regulated environments, and cross-functional process improvement.

Responsibilities

• Own and continuously improve global Supplier Change Notification (SCN) and Approved Supplier List (ASL) processes.
• Lead quality reviews and cross-functional teams, serving as a subject matter expert for supplier change notifications.
• Review and approve Supplier Change Notifications within the Quality Management System (QMS).
• Oversee quality-related activities associated with the Approved Supplier List for GMP material suppliers supporting drug substance and drug product manufacturing.
• Establish and monitor key performance indicators (KPIs), conduct trend analysis, and lead periodic process reviews to identify improvement opportunities.
• Implement risk-based approaches to supplier change management and ensure consistent application of processes across the supplier network.
• Develop, maintain, and communicate quality policies, procedures, governance structures, and controls.
• Collaborate with Supply Chain, Compliance, Global Sourcing and Procurement, Manufacturing Sciences and Technology, and site-level stakeholders to improve workflows and supplier performance.
• Support process enhancements and continuous improvement initiatives aligned with organizational goals and regulatory requirements.
• Provide subject matter expertise during internal and external inspections and support responses to inspection observations.
• Ensure processes remain compliant with applicable global health authority requirements and GMP/GDP regulations.

Qualifications

• Bachelor’s degree in Life Sciences or a related field.
• 6+ years of experience in biotechnology, pharmaceutical, medical device, or another highly regulated industry.
• Experience in Supplier Quality, Quality Compliance, Manufacturing Quality, Regulatory, or a related function.
• Strong knowledge of GMP/GDP regulations, quality systems, and supplier management processes.
• Experience with supplier change notifications, approved supplier management, or supplier quality programs.
• Demonstrated ability to lead cross-functional initiatives and drive process improvements in a matrixed organization.
• Strong project management, organizational, and analytical skills, including the ability to track complex initiatives and evaluate process performance.
• Excellent communication and stakeholder management skills, with the ability to influence decisions and drive accountability across teams.
• Ability to present data, justify quality decisions, and communicate effectively with management and regulatory inspectors.
• Knowledge of international regulatory requirements and experience supporting inspections preferred.