Sr Quality Specialist, Supplier Quality (Auditor)

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE^® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Job Summary: (On-site in Seal Beach, CA) The Senior Specialist in 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.

• Work closely with Sourcing/Procurement and Operations to ensure and manage the Quality of Supplier Goods (Raw Materials) produced by GMP suppliers, Contract Manufacturing Organizations (CMOs) and Service Providers
• Ensure appropriate quality agreements, standards and specifications are established and maintained with Suppliers and Service Providers in accordance with local/Federal regulations and established Quality Agreements
• Provide and implement solutions to Supplier and CMO issues that arise which could impact compliance to applicable regulations and Dendreon Quality Systems (including escalation to Leadership)
• Support and manage the planning and maintenance of annual audit program schedule, including coordinating audits as assigned.
• Lead, perform, and report audits to address qualification, routine, or suspected critical issues at CMOs, CTOs, vendors, suppliers, and clinical sites, ensuring vendors have quality and production systems that meet applicable regulatory, GxP requirements, and Company SOPs
• Write and issue audit reports in accordance with Company SOPs, templates, and timelines ensuring clear communication of audit findings to the Quality and cross functional team members
• Assess auditee’s capabilities, technology, data integrity practices, and regulatory compliance practices and recommend necessary changes to ensure adherence to standards when non-compliance is identified
• Issue Supplier Corrective actions and other supplier notifications for critical findings, follow-up with vendors on the implementation of corrective actions
• Evaluate vendor’s responses, track deliverables, and follow up on actions to closure (i.e., Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs)) to ensure timely completion, effectiveness, and quality
• Optimize new and existing SOPs to maintain and improve quality standards
• Support supplier quality management activities to be in a state of continued compliance

Requires minimal instructions on day-to-day work and new assignments. Perform other quality related tasks or initiatives, as assigned.

Scope:

• An experienced Quality Auditor with significant GMP experience within Supplier Quality, Quality Engineering, Auditing, and supplier relationship management
• A leader and problem solver who works with abstract ideas or situations across functional areas of the business internally and externally to resolve challenging Supplier issues
• Maintain and build effective relationships with key internal stake holders (Site Quality, Procurement, and Operations) with regards to supplier quality
• Provide GMP Suppliers and Service Provider criticality classification including: Risk Assessments, Risk mitigation planning, and monitoring
• Assess and evaluate supplier changes from a quality perspective
• Maintain and Manage Supplier external audit schedule and for cause audits
• Perform routine onsite audits/assessments at suppliers and CMO facilities
• Author and maintain up to date Supplier and Service Provider Quality Agreements
• Report Supplier Critical Quality Metrics to Management

• Bachelor’s degree in science/technical field (e.g., biochemistry, bioengineering, clinical research, etc.), or equivalent combined education and experience; Master’s degree a plus
• At least 8 years of experience in a quality/compliance-based role with relevant audit management/execution and inspection readiness experience
• Extensive experience in GxP auditing covering GMP, GVP, and GLP functions; GCP experience is a plus. A minimum of 5 years of experience as a lead auditor.
• Extensive knowledge and application of ALCOA+ standard, GxP, and global guidelines
• Current and strong working knowledge, interpretation, and implementation of United States FDA Regulations, ICH Guidelines, and other local government regulatory requirements governing biopharmaceutical research
• Ability to interpret and apply regulations, regulatory guidance, and identify and recommend compliance changes as appropriate
• Highly diplomatic and tactful individual with exceptional critical reasoning skills
• Well-organized and detailed oriented professional with excellent verbal and written communication skills
• Self-motivated with the ability to function independently and within a team in a fast-paced environment
• Flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events
• Ability to follow up on multiple tasks simultaneously
  Air and overnight travel will be required 30-50% for this poisition
• ASQ/ISO auditing experience a plus
• ASQ Certified Auditor is a plus
• Knowledge of MasterControl Quality Management systems is a plus

Working Conditions and Physical Requirements:

• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.