Senior Director Supplier Quality

Arcutis Biotherapeutics • US,

2d • $240,000 - $255,000

About The Position

The Senior 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.

Requirements

• 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.
• 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

Nice To Haves

• Experience with biologics, combination products and medical devices a plus.
• Experience in SAP, Veeva QMS a plus

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior