Bachelor's degree in engineering, biology, biochemistry, chemistry, pharmaceutical sciences, or related field.
7+ years of progressive Quality experience in regulated environments like pharmaceuticals or biotechnology.
2+ years of leadership experience in quality management or cross-functional initiatives.
Experience with supplier qualification, auditing, and quality risk management.
Strong knowledge of cGMP and quality-system requirements.
Excellent communication skills for influencing stakeholders.
Proficient in Microsoft Office and quality management systems.
Responsibilities
Lead and enhance the Supplier Quality program in line with cGMP requirements.
Establish risk-based approaches for supplier qualification and monitoring.
Review and approve suppliers and raw materials for compliance.
Monitor supplier quality metrics and drive corrective actions as needed.
Oversee investigations and corrective actions for supplier-related issues.
Develop and conduct risk-based supplier audits and maintain inspection readiness.
Collaborate with cross-functional teams to manage supplier-related quality risks.
Benefits
Onsite presence required 5 days a week at Seal Beach location.
Opportunity for professional growth in a leadership role.
Engagement with cross-functional teams across the organization.
Potential for travel to supplier locations as needed.
Work in a dynamic environment with a focus on continuous improvement.
Full Job Description
Job 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, 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.
Audits & Inspection Readiness
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 management, team leadership, or leading cross-functional quality initiatives in a regulated environment.
Demonstrated experience with supplier qualification, supplier auditing, raw-material quality, investigations, CAPA, change control, deviations/nonconformances, and quality risk management.
Experience supporting regulatory inspections and maintaining inspection readiness.
Strong working knowledge of cGMP and quality-system requirements applicable to pharmaceutical or biologics operations.
Strong written and verbal communication skills with the ability to influence suppliers and cross-functional stakeholders.
Strong organizational and project-management skills with the ability to manage multiple priorities and deadlines.
Proficiency with Microsoft Office and electronic quality-management or enterprise systems.
Preferred Experience & Skills
Advanced degree in a scientific, engineering, quality, or business discipline.
Experience with contract laboratories, 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
About Dendreon
Dendreon is a biotechnology company that develops immunotherapy treatments for cancer. The company was founded in 1992 and is headquartered in Seattle, Washington. Dendreon's flagship product, Provenge, is an immunotherapy treatment for prostate cancer that was approved by the FDA in 2010. The company has faced financial difficulties in recent years, including filing for bankruptcy in 2014. In 2017, Dendreon was acquired by Chinese conglomerate, Sanpower Group.
