Sr Quality Specialist, Supplier Quality

Senior Quality Specialist, Supplier Quality

The Senior Quality Specialist, Supplier Quality is responsible for ensuring that Dendreon's GMP suppliers, including Contract Manufacturers (CMOs), component suppliers, and service providers, comply with local and federal regulations as well as Dendreon's internal quality standards and specifications. This role is essential in maintaining a compliant and reliable supply chain while upholding the highest quality and regulatory standards.

Responsibilities

Key Responsibilities :

• Serve as the primary Quality point of contact for assigned GMP suppliers, Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and service providers.
• Ensure the quality and compliance of externally sourced materials, components, and services through effective oversight, qualification, and ongoing monitoring.
• Lead and conduct domestic and international supplier audits (qualification, surveillance, and for-cause), including pre-audit planning, execution, documentation, and follow-up.
• Author high-quality, risk-based audit reports in accordance with internal procedures and regulatory expectations; clearly communicate findings, risk assessments, and required corrective actions.
• Maintain auditing proficiency through ongoing training or certification (e.g., ASQ Certified Quality Auditor, or equivalent). Previous auditing experience in a GMP-regulated environment is required.
• Issue and manage Supplier Corrective and Preventive Actions (CAPAs); assess responses for adequacy, verify implementation, and perform effectiveness checks to closure.
• Conduct supplier risk assessments and provide criticality classifications to guide oversight strategy; implement and track risk mitigation plans.
• Review and assess supplier change notifications, deviation reports, and investigations for potential impact to product quality, supply chain, and regulatory compliance.
• Collaborate with cross-functional teams to ensure timely resolution of quality issues and communication of quality risks related to suppliers and CMOs.
• Establish, negotiate, and maintain Quality Agreements and technical documentation with external partners to ensure alignment with regulatory requirements and corporate policies.
• Support receipt, review, and disposition of materials by ensuring supplier documentation is complete, accurate, and compliant.
• Monitor and report Supplier Quality performance metrics (e.g., audit findings, CAPA timelines, on-time delivery, right-first-time rates) to internal stakeholders and management.
• Maintain and optimize Supplier Quality SOPs, workflows, audit tools, and related documentation to support an efficient and compliant supplier oversight program.
• Support regulatory inspections and internal audits by representing the Supplier Quality function, retrieving documentation, and responding to supplier-related inquiries or observations.
• Stay current with evolving regulatory expectations and industry best practices related to supplier quality, external manufacturing oversight, and auditing.
• Lead or contribute to strategic quality improvement initiatives, cross-functional projects, and continuous improvement efforts across the Supplier Quality program.
• Perform other quality-related duties or initiatives as assigned, with minimal supervision.

Qualifications

Required Experience & Skills :

Preferred Experience :

Working Conditions and Physical Requirements :