Manager, Supplier Quality

Dendreon Pharmaceuticals LLC•Seal Beach, CA

6d•$125,700 - $164,248•Onsite

About The Position

The Manager, Supplier Quality leads the Supplier Quality team and provides strategic oversight of supplier quality activities supporting Dendreon’s clinical and commercial operations. The role develops and executes a risk-based supplier audit and qualification strategy, monitors supplier performance, and oversees 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. The role requires onsite presence five days a week at the Seal Beach location when not traveling. Work may take place in office, laboratory, warehouse, and manufacturing environments. The employee must comply with applicable gowning, hygiene, safety, and PPE requirements in regulated areas. Occasional work outside normal business hours and travel of up to 25% to supplier or company locations may be required.

Requirements

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.
Ability to 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.

Nice To Haves

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).

Responsibilities

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.
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.
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.
Perform other duties as assigned.