Supplier Quality Management Process Manager

GForce Life Sciences; Novato (CA); Hybrid; USD 140,000 - 180,000; Full time

Job summary

GForce Life Sciences in Novato, CA seeks a Supplier Quality Management Process Manager on a 12‑month contract. The role oversees global SCN and ASL processes, drives continuous improvement, and partners with cross‑functional teams to ensure GMP compliance and robust supplier quality practices.

Qualified candidates will have 6+ years in regulated biotech/pharma settings, expertise in QMS and supplier programs, and strong project-management and communication skills for regulatory inspections and

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 6+ years of experience in biotechnology, pharmaceutical, medical device, or other highly regulated industry.
• Experience in Supplier Quality, Quality Compliance, Manufacturing Quality, Regulatory, or 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.
• Excellent communication and stakeholder management skills, with ability to influence decisions.
• Knowledge of international regulatory requirements and experience supporting inspections preferred.

Responsibilities

• Own and continuously improve global SCN and ASL processes.
• Lead quality reviews and cross-functional teams as SME for supplier change notifications.
• Review and approve SCN within the QMS.
• Oversee quality-related activities for ASL supporting GMP material suppliers.
• Establish and monitor KPIs, perform trend analysis, and lead process reviews.
• Implement risk-based approaches to supplier change management.
• Develop, maintain, and communicate quality policies, procedures and controls.
• Collaborate with Supply Chain, Compliance, Global Sourcing, Manufacturing Sciences and Technology, and site stakeholders.
• Support process enhancements and continuous improvement aligned with regulatory requirements.
• Provide SME support during inspections and respond to observations.
• Ensure processes remain compliant with global health authority requirements and GMP/GDP.

Skills

Supplier Quality Management

GMP/GDP

QMS

Process Improvement

Regulatory Compliance

Project Management

Cross-functional Leadership

Inspection Readiness

Data Analysis

Stakeholder Management

Education

Bachelor’s degree in Life Sciences

Job description

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.