Senior Supplier Quality Auditor – Global GMP Audits

Dendreon Pharmaceuticals; Seal Beach (CA); On-site; USD 117,000 - 153,000; Full time

Job summary

Dendreon Pharmaceuticals is seeking a Sr. Vendor Quality Auditor, Supplier Quality in Seal Beach, CA to oversee supplier quality for external partners including CMOs/CTOs. The role leads audits, evaluates supplier risk, and ensures compliance with FDA, EU, and ICH standards.

You will collaborate with Quality, Manufacturing, Regulatory Affairs, and Supply Chain to strengthen the supplier network and support regulatory inspections. Travel 30–50% is anticipated.

Qualifications

• Bachelor's degree required in a scientific discipline; advanced degree preferred.
• Minimum 8 years in Quality Assurance, Supplier Quality, Compliance, or Quality Systems in regulated environments.
• Minimum 5 years leading GxP supplier audits.
• Strong knowledge of FDA, ICH, EU GMP and GxP principles.

Responsibilities

• Represent Supplier Quality for assigned suppliers and external partners.
• Lead domestic and international supplier audits from planning to follow-up.
• Prepare clear, risk-based audit reports and communicate findings.
• Manage supplier CAPAs and verify effectiveness.
• Conduct supplier qualification and periodic risk assessments.

Skills

Auditing

GxP compliance

Regulatory knowledge

Vendor management

Cross-functional collaboration

Communication

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, Quality, Regulatory Affairs, or related scientific discipline

Master's degree in a scientific discipline

ASQ CQA or ISO Lead Auditor

Tools

MasterControl eQMS

MS Office

Job description

Dendreon Pharmaceuticals is seeking a Sr. Vendor Quality Auditor, Supplier Quality in Seal Beach, CA to oversee supplier quality for external partners including CMOs/CTOs. The role leads audits, evaluates supplier risk, and ensures compliance with FDA, EU, and ICH standards.

You will collaborate with Quality, Manufacturing, Regulatory Affairs, and Supply Chain to strengthen the supplier network and support regulatory inspections. Travel 30–50% is anticipated.