Manager, Supplier Quality

Manager, Supplier Quality

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.

The Manager, Supplier Quality leads the Supplier Quality team and provides strategic oversight of supplier quality activities supporting the company's clinical and commercial operations. This role is responsible for developing and executing a risk-based supplier audit and qualification strategy, monitoring supplier performance, and overseeing raw material quality, investigations, CAPA, and change control.

The Manager partners cross-functionally to mitigate supplier-related risks, ensure compliance with applicable cGMP and regulatory requirements, drive continuous improvement, and maintain inspection readiness.

Note:

This role requires onsite presence 5 days a week at our Seal Beach location when not traveling.

Key Responsibilities:

• Lead and continuously improve the Supplier Quality program in accordance with applicable cGMP requirements and company procedures.
• Establish and apply risk-based approaches for supplier qualification, classification, monitoring, and requalification.
• Review and approve suppliers, contract laboratories, raw materials, and externally provided GMP products and services.
• Monitor supplier quality metrics, trends, and performance; identify risks and drive appropriate corrective or improvement actions.
• Provide Quality input into supplier selection and sourcing decisions based on supplier capability, compliance history, and risk.
• Maintain supplier quality documentation and systems in an inspection-ready state.
• Oversee the review and disposition of GMP raw materials against approved specifications and regulatory requirements.
• Lead or oversee supplier-related deviations, nonconformances, material defects, investigations, and contract laboratory issues.
• Manage supplier corrective actions and evaluate root-cause analyses, CAPAs, and effectiveness.
• Review and approve supplier-related changes and assess potential impact to product quality, validated processes, regulatory commitments, and continuity of supply.
• Apply sound scientific and quality judgment to make timely, risk-based decisions and appropriately escalate significant concerns.
• Develop and support risk-based supplier audit plans and conduct or oversee audits of suppliers, contract manufacturers, contract laboratories, and other external service providers.
• Review audit findings and supplier responses and ensure commitments are appropriately addressed through closure.
• Represent Supplier Quality during internal audits, customer audits, and regulatory inspections.
• Maintain ongoing inspection readiness for supplier and raw-material quality activities.
• Partner with Manufacturing, Quality Control, Quality Assurance, Supply Chain, Procurement, Regulatory Affairs, Technical Operations, Validation, and other functions to identify and manage supplier-related quality risks.
• Provide Quality support for technology transfers, process changes, validation activities, supplier transitions, and new materials.
• Communicate technical and compliance requirements clearly and effectively to suppliers and internal stakeholders.
• Analyze supplier quality data and trends to identify emerging risks and opportunities for continuous improvement.
• Drive improvements in supplier performance, compliance, cycle times, and process effectiveness.
• Manage multiple priorities and deadlines while balancing quality, compliance, and operational needs.
• Other duties as assigned.

Job Requirements:

Required Experience & Skills

• Bachelor's degree in engineering, biology, biochemistry, chemistry, pharmaceutical sciences, or a related scientific or technical discipline.
• Typically 7+ years of progressive Quality experience in pharmaceutical, biotechnology, biologics, medical device, or another regulated environment.
• Minimum 2 years of leadership experience, including people…