Senior Director Supplier Quality

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Professional US

Salary Range: $240,000.00 To $255,000.00 Annually

TheSenior Director, Supplier Quality is accountable for establishing and maintaining a robust, risk-based supplier management program that ensures compliance with applicable GMP, GDP, and regulatory requirements while safeguarding product quality and patient safety. The Senior Director will lead a team of Supplier Quality professionals, oversee critical quality investigations and escalations, manage supplier performance and compliance activities, and serve as the primary quality representative for Arcutis’ distribution partners. This role requires strong leadership, technical expertise, and the ability to influence cross-functional stakeholders and external partners to drive quality excellence throughout the supply network.

• Lead, develop, and mentor a team of Supplier Quality professionals.
• Establish team strategy, goals, performance metrics, and development plans.
• Promote a culture of quality, accountability, continuous improvement, and inspection readiness.
• Provide strategic direction and resource planning to support commercial and development programs.
• Oversight of suppliers involved in the packaging, labeling and distribution of Arcutis commercial and clinical products. Including management of Quality Agreements with artwork vendors, 3PL and pack/label contractors
• Commercial artwork review and approval.
• Release of Finished Products for distribution in US.
• Review of batch-related documentation to ensure GMP compliance for release of Finished Product.
• Lead and oversee significant quality investigations associated with supplier operations, manufacturing, testing, packaging, labeling, storage, and distribution activities.
• Ensure robust root cause analysis and development of effective corrective and preventive actions (CAPAs).
• Evaluate product impact and patient risk associated with investigations and quality events.
• Support health authority commitments, product recalls, field actions, and market actions as required.
• Escalate significant quality, compliance, and supply risks to executive management.

Education & Licenses and Experience

Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Pharmacy, Engineering, or related scientific discipline required. Minimum 12 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. Minimum 5 years of leadership experience managing quality professionals. Extensive experience overseeing CMOs, contract testing laboratories, and third-party logistics providers.

• Expert knowledge of pharmaceutical quality systems and supplier quality management.
• Strong understanding of risk management principles, deviation management, CAPA, change control, and complaint handling.
• Proven ability to influence both internal and external stakeholders.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent verbal and written communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Demonstrated leadership presence and executive communication skills.
• Ability to lead and influence cross functional employees to ensure compliance.
• Experience with biologics, combination products and medical devices a plus.
• Ability to effectively present information in small and large group situations to staff, partners, regulators, and executive management.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Proficient in MS Word, Excel, Power Point, Smartsheet
• Experience in SAP, Veeva QMS a plus
• Domestic and international travel of approximately 10-20% may be required to support supplier audits, governance meetings, inspections, and business needs.

Why Join Us?

Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!

This job description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.