Sr. Vendor Quality Auditor, Supplier Quality

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At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product,
PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease.
If you’re driven by the opportunity to make a meaningful impact on cancer patients’ lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a talented team of scientific, clinical, regulatory, and corporate professionals based in Seal Beach, and a commercial organization operating across the United States, Dendreon continues to advance innovation in personalized cancer treatment.
CORE VALUES:

• Put Patients First: Every day is an opportunity to improve the lives of those living with cancer.
• Act with Integrity: We commit to transparency, honesty, and always doing what’s right.
• Build Trust: Trust is earned through candid, open communication and a collaborative approach.
• Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people.
• Drive Results: We are accountable to each other and deliver success together.

Job Summary:
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.


Key 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.

Job Requirements:

Required Experience & Education:

• 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…