Manager, Supplier Quality

The posting, as Dendreon Pharmaceuticals LLC wrote it

WHO WE ARE

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.

Jo b Summary

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

Supplier Quality & Compliance

• 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.

Raw Materials, Investigations & CAPA

• Oversee the review and disposition of GMP raw materials against approved specifications and regulatory requirements.
• Lead or oversee supplier-related deviations, nonconformances, mat

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tories, contract manufacturers, critical material suppliers, or other GMP service providers.

• Experience in biologics, cell therapy, or aseptic manufacturing environments.
• Knowledge of Lean, Six Sigma, statistical methods, or continuous-improvement practices.
• Relevant professional certification such as ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Working Conditions and Physical Requirements

• Work may be performed in office, laboratory, warehouse, and manufacturing environments.
• Must comply with applicable gowning, hygiene, safety, and PPE requirements in regulated areas.
• Ability to work occasionally outside normal business hours and travel up to 25% to supplier or company locations, as business needs require.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

CA Compensation Range
$125,700 — $164,248 USD

Beware of Recruitment Scams

Please be aware of the potential for scams from individuals, organizations and internet sites that claim to represent Dendreon Pharmaceuticals in recruitment activities. We strongly recommend that you verify all communications you receive about positions at Dendreon. Any communications from Dendreon would come from an email address that ends in “@ dendreon.com ”. Dendreon will never ask candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the recruitment or offer process. Dendreon conducts a formal recruitment process for all authorized positions posted and does not conduct interviews via social media, or other third-party sites or chat services. If you are unsure about a posting or email you receive, please contact us at AskHR@dendreon.com . If you believe you are a victim of fraud, please contact your local law enforcement.