Senior Manager, Supplier Quality & Compliance

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

Job summary

Dendreon is seeking a Manager of Supplier Quality to lead and mature the supplier quality program supporting clinical and commercial operations in Seal Beach. You will drive risk-based supplier qualification, oversight of raw materials, investigations, CAPA, and change control, and collaborate across functions to ensure regulatory compliance.

The role requires on-site presence five days a week at the Seal Beach location, with responsibilities spanning audits, supplier performance monitoring, and

Qualifications

• Bachelor’s degree in engineering, biology, biochemistry, chemistry, pharmaceutical sciences, or related field.
• Typically 7+ years of progressive Quality experience in pharma/biotech/regulated environments.
• Minimum 2 years of leadership experience with cross‑functional teams.
• Demonstrated experience with supplier qualification, supplier auditing, raw-m material quality, investigations, CAPA, change control and risk management.
• Experience supporting regulatory inspections and maintaining inspection readiness.
• Strong knowledge of cGMP and quality-system requirements.

Responsibilities

• Lead and continuously improve the Supplier Quality program in line with cGMP requirements.
• Establish risk-based supplier qualification, monitoring, and requalification.
• Review and approve suppliers, contract labs, raw materials, and externally provided GMP services.
• Monitor supplier quality metrics and drive corrective actions and improvements.
• Provide QA input into supplier selection and sourcing decisions.
• Maintain supplier quality documentation and systems in an inspection-ready state.
• Develop and support risk-based supplier audit plans and conduct/oversee audits.
• Represent Supplier Quality during internal, customer, and regulatory inspections.

Skills

Supplier Quality

Leadership

cGMP

Quality Risk Mgmt

Audits

Regulatory Inspections

Communication

Project Mgmt

Analytical Skills

Education

Bachelor’s degree in engineering/biological sciences

Tools

Quality management systems

Job description

Dendreon is seeking a Manager of Supplier Quality to lead and mature the supplier quality program supporting clinical and commercial operations in Seal Beach. You will drive risk-based supplier qualification, oversight of raw materials, investigations, CAPA, and change control, and collaborate across functions to ensure regulatory compliance.

The role requires on-site presence five days a week at the Seal Beach location, with responsibilities spanning audits, supplier performance monitoring, and