Senior Supplier Quality Auditor - GxP Compliance

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

Job summary

Dendreon in Seal Beach, CA, seeks a Senior Vendor Quality Auditor, Supplier Quality to oversee the quality and compliance of external suppliers, CMOs, CTOs, and service providers. You will lead qualification and surveillance audits, assess risk, and drive corrective actions to maintain a compliant supply chain.

Collaborating with Quality, Manufacturing, Regulatory Affairs, and Supply Chain, you will maintain audit documentation, manage CAPAs, and contribute to continuous improvement while

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, Quality, Regulatory Affairs, or related scientific discipline.
• Minimum 8 years of experience in Quality Assurance, Supplier Quality, Compliance, or Quality Systems within a regulated pharmaceutical/biotech environment.
• Minimum 5 years of experience conducting and leading GxP supplier audits.
• Strong knowledge of FDA regulations, ICH guidelines, EU GMP requirements, and GxP principles.
• Demonstrated experience managing supplier qualification, supplier performance monitoring, CAPAs, investigations, and Quality Agreements.
• Ability to travel approximately 30-50% (domestic and international).

Responsibilities

• Serve as the primary Supplier Quality representative for assigned suppliers, CMOs, CTOs, and service providers.
• Lead and conduct domestic and international supplier audits, including qualification, surveillance, and for-cause audits.
• Prepare clear, risk-based audit reports and communicate audit observations and corrective actions.
• Manage supplier CAPAs, including evaluation of responses and effectiveness assessments.
• Perform supplier qualification and periodic risk assessments to establish oversight strategies.
• Review supplier change notifications, deviations, investigations, and quality events for impact on product quality and compliance.
• Establish and maintain Quality Agreements with suppliers and partners.
• Monitor supplier performance through metrics and scorecards and drive improvements.
• Collaborate with Manufacturing, Supply Chain, Regulatory Affairs, Technical Operations, and Quality teams to resolve supplier-related quality issues.
• Maintain audit documentation and QMS records in inspection readiness.
• Support regulatory inspections and audits with supplier quality documentation.

Skills

Quality Assurance

Supplier Quality

Regulatory Affairs

Stakeholder Management

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, Quality, Regulatory Affairs

Master's degree (preferred)

Tools

MasterControl

Job description

Dendreon in Seal Beach, CA, seeks a Senior Vendor Quality Auditor, Supplier Quality to oversee the quality and compliance of external suppliers, CMOs, CTOs, and service providers. You will lead qualification and surveillance audits, assess risk, and drive corrective actions to maintain a compliant supply chain.

Collaborating with Quality, Manufacturing, Regulatory Affairs, and Supply Chain, you will maintain audit documentation, manage CAPAs, and contribute to continuous improvement while