Sr. Vendor Quality Auditor, Supplier Quality

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.

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:

• 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.

Preferred Experience & Education:

• 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.

Working Conditions and Physical Requirements:

• This role operates in a standard office setting using standard office equipment.
• Role requires frequent use of video conferencing, standard office software, and digital collaboration tools.
• Must have the ability to lift 10 – 20 lbs.
• Must have the ability to work in an office environment around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

Dendreon is an equal employment and affirmative action employer F/M/Disability/Vet/Sexual Orientation/Gender Identity. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

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.