Strategic Supplier Quality Manager

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

Job summary

Dendreon Pharmaceuticals is seeking a Manager, Supplier Quality to lead the supplier quality team and oversee risk-based audits, material quality, investigations, CAPA, and change control. This onsite role in Seal Beach CA requires coordinating with cross-functional teams to ensure compliance and continuous improvement.

You will partner with Manufacturing, Regulatory Affairs, and Procurement to mitigate supplier risks, maintain inspection readiness, and drive timely quality decisions.

Qualifications

• Bachelor’s degree in a related scientific or technical discipline.
• Similarly, 7+ years of progressive Quality experience in regulated environments.
• Minimum 2 years of leadership experience in cross-functional teams.
• Experience with supplier qualification, auditing, raw-material quality, investigations, CAPA, and change control.
• 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 accordance with cGMP requirements.
• Establish risk-based approaches for supplier qualification, monitoring, and requalification.
• Review and approve suppliers, contract labs, raw materials, and externally provided GMP products/services.
• Monitor supplier quality metrics, trends and performance; drive corrective actions.
• Provide Quality 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 audits.

Skills

Quality leadership

Supplier qualification

Supplier auditing

CAPA & investigations

Change control

Regulatory inspections

cGMP knowledge

Quality risk management

Communication

Project management

Education

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

Job description

Dendreon Pharmaceuticals is seeking a Manager, Supplier Quality to lead the supplier quality team and oversee risk-based audits, material quality, investigations, CAPA, and change control. This onsite role in Seal Beach CA requires coordinating with cross-functional teams to ensure compliance and continuous improvement.

You will partner with Manufacturing, Regulatory Affairs, and Procurement to mitigate supplier risks, maintain inspection readiness, and drive timely quality decisions.