Senior Supplier Quality & Compliance Manager

Dendreon Pharmaceuticals LLC; Seal Beach (CA); On-site; USD 126,000 - 164,000; Full time

Job summary

Dendreon Pharmaceuticals LLC is seeking a Manager, Supplier Quality to lead the Supplier Quality team and shape the strategy for supplier qualification, audits, and material quality across clinical and commercial operations in Seal Beach.

The role partners with Manufacturing, Regulatory, and Supply Chain to ensure compliance with cGMP, drive CAPA and change control, and maintain inspection readiness while leading risk-based improvements and supplier performance.

Qualifications

• Bachelor's degree in engineering, biology, biochemistry, chemistry, pharmaceutical sciences, or related scientific/technical field.
• 7+ years of progressive Quality experience in pharma/biotech/regulated environments.
• 2+ years of leadership experience in a regulated environment.

Responsibilities

• Lead and continuously improve the Supplier Quality program in accordance with cGMP requirements.
• Establish risk-based supplier qualification, monitoring, and requalification processes.
• Review and approve suppliers, contract laboratories, raw materials, and externally provided GMP products/services.
• Monitor supplier quality metrics and drive corrective actions and improvements.
• Provide QA input into supplier selection and sourcing decisions based on risk and compliance.
• Maintain supplier quality documentation and systems in an inspection-ready state.
• Develop and support risk-based supplier audit plans and conduct audits.
• Represent Supplier Quality during internal audits, customer audits, and regulatory inspections.
• Collaborate with cross-functional teams to manage supplier-related risks and improvements.

Skills

Leadership experience

Quality systems & cGMP

Supplier qualification

Regulatory inspections

Cross-functional collaboration

Education

Bachelor's degree in engineering, biology, biochemistry, chemistry, pharmaceutical sciences, or related field

Job description

Dendreon Pharmaceuticals LLC is seeking a Manager, Supplier Quality to lead the Supplier Quality team and shape the strategy for supplier qualification, audits, and material quality across clinical and commercial operations in Seal Beach.

The role partners with Manufacturing, Regulatory, and Supply Chain to ensure compliance with cGMP, drive CAPA and change control, and maintain inspection readiness while leading risk-based improvements and supplier performance.