Sr. Vendor Quality Auditor, Supplier Quality

Dendreon Pharmaceuticals LLC•Seal Beach, CA

3d•Hybrid

About The Position

The Senior Vendor Quality Auditor, Supplier Quality is responsible for overseeing the quality and compliance of Dendreon's external suppliers, Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and service providers. This role leads supplier qualification and surveillance audit activities, assesses supplier performance and risk, manages supplier quality issues, and ensures compliance with applicable GxP regulations and Dendreon quality standards. The position serves as a key partner to Quality, Manufacturing, Supply Chain, Regulatory Affairs, and other cross-functional teams to support a compliant and reliable supply network.

Requirements

Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, Quality, Regulatory Affairs, or a related scientific discipline.
Minimum 8 years of experience in Quality Assurance, Supplier Quality, Compliance, or Quality Systems within a regulated pharmaceutical, biotechnology, biologics, cell therapy, or medical device 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.
Proven ability to assess compliance risks and implement effective corrective actions.
Experience supporting regulatory inspections and responding to supplier-related observations.
Strong verbal, written, organizational, and stakeholder management skills.
Proficiency with Microsoft Office applications.
Ability to travel approximately 30-50%, including domestic and international travel.

Nice To Haves

Master's degree in a scientific discipline.
ASQ Certified Quality Auditor (CQA), ISO Lead Auditor, or equivalent certification.
Experience auditing CMOs, CTOs, raw material suppliers, laboratories, and service providers supporting biologics, cell therapy, or pharmaceutical manufacturing.
Experience with electronic Quality Management Systems (eQMS), such as MasterControl.
Knowledge of supplier quality risk management methodologies and supplier performance programs.
Experience supporting global supplier networks and international regulatory requirements.

Responsibilities

Serve as the primary Supplier Quality representative for assigned suppliers, Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and service providers.
Lead and conduct domestic and international supplier audits, including qualification, surveillance, and for-cause audits, from planning through report issuance and follow-up.
Prepare clear, risk-based audit reports and communicate audit observations, compliance risks, and recommended corrective actions.
Manage supplier CAPAs, including evaluation of responses, verification of implementation, and effectiveness assessments.
Perform supplier qualification and periodic risk assessments to establish appropriate oversight strategies.
Review supplier change notifications, deviations, investigations, and quality events to determine impact on product quality, regulatory compliance, and business operations.
Establish and maintain Quality Agreements with suppliers and external partners to ensure alignment with regulatory and corporate requirements.
Monitor supplier performance through quality metrics, trends, and scorecards, recommending improvements when necessary.
Partner with Manufacturing, Supply Chain, Regulatory Affairs, Technical Operations, and Quality teams to resolve supplier-related quality issues and mitigate risk.
Maintain supplier qualification records, audit documentation, and related quality system documentation in a state of inspection readiness.
Support regulatory inspections, customer audits, and internal audits by providing supplier quality documentation and subject matter expertise.
Contribute to continuous improvement initiatives that enhance supplier quality processes, audit effectiveness, and external partner oversight.
Remain current on applicable FDA, EU, ICH, and global regulatory requirements related to supplier quality and auditing.
Perform additional duties as assigned.