Senior Director, Supplier Quality & Compliance

Arcutis Biotherapeutics, Inc.; Northern (KY); Hybrid; USD 240,000 - 255,000; Full time

Job summary

Arcutis Biotherapeutics, Inc. is seeking a Senior Director, Supplier Quality to establish and manage a risk-based supplier program ensuring GMP, GDP, and regulatory compliance, protecting product quality and patient safety.

The role leads a team of supplier quality professionals and oversees critical investigations across packaging, labeling, and distribution with external partners, including QA of third parties.

Qualifications

• Bachelor’s degree in Life Sciences or related field required.
• Minimum 12 years of GMP-related experience in biotech/pharma.
• Minimum 5 years of leadership experience managing quality professionals.
• Experience overseeing CMOs, contract labs, and 3PLs.

Responsibilities

• Lead, develop, and mentor a team of Supplier Quality professionals.
• Establish team strategy, goals, metrics, and development plans.
• Provide strategic direction to support commercial and development programs.
• Oversee packaging, labeling, and distribution QA for Finished Products.
• Review batch-related documentation to ensure GMP compliance.
• Lead significant supplier quality investigations and CAPAs.
• Escalate risks to executive management.
• Support regulatory commitments, recalls, and field actions.

Skills

Leadership

Supplier quality management

GMP knowledge

CAPA

Root cause analysis

Cross-functional collaboration

Regulatory compliance

Audit/inspections

Change control

Data analysis

Education

Bachelor’s degree in Life Sciences

Tools

MS Word

Excel

PowerPoint

Smartsheet

SAP

Veeva QMS

Job description

Arcutis Biotherapeutics, Inc. is seeking a Senior Director, Supplier Quality to establish and manage a risk-based supplier program ensuring GMP, GDP, and regulatory compliance, protecting product quality and patient safety.

The role leads a team of supplier quality professionals and oversees critical investigations across packaging, labeling, and distribution with external partners, including QA of third parties.