Global Supplier Quality Process Lead - SCN/ASL (Hybrid)

GForce Life Sciences

Novato (CA)

Hybrid

USD 140,000 - 180,000

Full time

25 hours ago
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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

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

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