Sr Quality Specialist, Supplier Quality

The Senior Quality Specialist, Supplier Quality is responsible for ensuring that Dendreon’s GMP suppliers, including Contract Manufacturers (CMOs), component suppliers, and service providers, comply with local and federal regulations as well as Dendreon’s internal quality standards and specifications. This role is essential in maintaining a compliant and reliable supply chain while upholding the highest quality and regulatory standards.

Key Responsibilities:

• Serve as the primary Quality point of contact for assigned GMP suppliers, Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and service providers.
• Ensure the quality and compliance of externally sourced materials, components, and services through effective oversight, qualification, and ongoing monitoring.
• Lead and conduct domestic and international supplier audits (qualification, surveillance, and for-cause), including pre-audit planning, execution, documentation, and follow-up.
• Author high-quality, risk-based audit reports in accordance with internal procedures and regulatory expectations; clearly communicate findings, risk assessments, and required corrective actions.
• Maintain auditing proficiency through ongoing training or certification (e.g., ASQ Certified Quality Auditor, or equivalent). Previous auditing experience in a GMP-regulated environment is required.
• Issue and manage Supplier Corrective and Preventive Actions (CAPAs); assess responses for adequacy, verify implementation, and perform effectiveness checks to closure.
• Conduct supplier risk assessments and provide criticality classifications to guide oversight strategy; implement and track risk mitigation plans.
• Review and assess supplier change notifications, deviation reports, and investigations for potential impact to product quality, supply chain, and regulatory compliance.
• Collaborate with cross-functional teams to ensure timely resolution of quality issues and communication of quality risks related to suppliers and CMOs.
• Establish, negotiate, and maintain Quality Agreements and technical documentation with external partners to ensure alignment with regulatory requirements and corporate policies.
• Support receipt, review, and disposition of materials by ensuring supplier documentation is complete, accurate, and compliant.
• Monitor and report Supplier Quality performance metrics (e.g., audit findings, CAPA timelines, on-time delivery, right-first-time rates) to internal stakeholders and management.
• Maintain and optimize Supplier Quality SOPs, workflows, audit tools, and related documentation to support an efficient and compliant supplier oversight program.
• Support regulatory inspections and internal audits by representing the Supplier Quality function, retrieving documentation, and responding to supplier-related inquiries or observations.
• Stay current with evolving regulatory expectations and industry best practices related to supplier quality, external manufacturing oversight, and auditing.
• Lead or contribute to strategic quality improvement initiatives, cross-functional projects, and continuous improvement efforts across the Supplier Quality program.
• Perform other quality-related duties or initiatives as assigned, with minimal supervision.

Required Experience & Skills:

• Bachelor’s degree in a scientific or technical field (e.g., Biochemistry, Bioengineering, Clinical Research, or related discipline).
• 8+ years of experience in Quality Assurance, Quality Systems, or Compliance within an FDA-regulated pharmaceutical, biopharmaceutical, or biotech environment.
• 5+ years of experience as a lead auditor, with demonstrated proficiency in planning, conducting, and reporting GxP audits (including GMP, GLP, and/or GVP).
• Strong working knowledge of FDA regulations, ICH guidelines, GxP principles, and ALCOA+ standards.
• Proven ability to interpret and apply regulatory requirements and identify compliance risks with actionable solutions.
• Experience supporting regulatory inspections and preparing for agency interactions (FDA or global).
• Excellent verbal and written communication skills, with the ability to clearly articulate technical issues and regulatory expectations.
• Strong organizational and multitasking skills; able to manage multiple priorities and deadlines independently.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Willing and able to travel 30–50%, including overnight and international travel to supplier and CMO sites.

Preferred Experience:

• Master’s degree in a relevant scientific or technical field.
• ASQ Certified Quality Auditor (CQA), ISO Lead Auditor, or equivalent auditing certification.
• Auditing experience in Good Clinical Practice (GCP) or across multiple GxP domains (GMP, GVP, GLP, GCP).
• Experience working with electronic Quality Management Systems (eQMS) such as MasterControl.
• Familiarity with supplier quality risk management tools and methodologies (e.g., risk assessments, supplier criticality classification).
• Strong collaboration and stakeholder engagement skills, with a track record of cross-functional partnership.

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.