Director, Quality Management Systems

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. The company focuses on developing innovative drugs for diseases with a genetic basis, leveraging RNAi technologies to address conditions across virtually any therapeutic area, including targets not addressable by small molecules and biologics.

About the role

The Director of Quality Management Systems (QMS) will oversee the GxP QMS to ensure compliance with regulatory requirements, industry standards, and company policies for the development, manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). This role involves leading a team of Quality professionals, providing strategic leadership in QMS development, and driving quality culture and continuous improvement initiatives. Arrowhead is advancing a broad pipeline of RNA-based therapies toward commercial readiness, and this role is critical in building and enhancing the quality infrastructure to support pre-approval inspection (PAI) readiness and beyond.

Responsibilities

• Develop, maintain, and optimize global QMS strategy and processes based on relevant regulatory requirements and aligned with corporate goals.
• Manage and oversee all aspects of GxP QMS functions for clinical and commercial products, including Document Control and Training; Non-conformance Management and CAPA; Internal QMS Audits; Quality Management Review; and Change and Risk Management.
• Monitor emerging regulatory trends and ensure proactive adaptation of process changes.
• Lead and support risk assessments using current industry best practices and methodologies.
• Partner with manufacturing, analytical development and quality control, supply chain, regulatory affairs, and clinical and non-clinical development teams to ensure alignment on quality and compliance objectives.
• Identify, assess, and mitigate GxP-related risks across relevant processes.
• Build, mentor, and lead a high-performing QMS team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
• Demonstrate strong leadership, analytical, problem-solving, and decision-making abilities.
• Organize priorities and communicate effectively in both written and verbal formats.
• Perform additional duties as requested.

Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field. Advanced degree preferred (PhD, MS, or equivalent).
• 10+ years of experience in the pharmaceutical or biotechnology industry, contract manufacturing organization, or contract research organization.
• 6+ years in QMS leadership with demonstrated experience leading a quality system through a clinical-to-commercial transition or pre-approval inspection readiness program.
• Knowledge of GMP and GDP regulations, as well as ICH/FDA, EU MDR, ISO 13485, including experience with development of applicable QMS and regulatory compliance programs.
• Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels.
• Strategic thinker with a focus on continuous improvement and innovation, comfortable working in a fast-paced, dynamic environment with evolving priorities.
• Ability for occasional business travel.
• Strong people and team leadership skills.
• Broad understanding of technical/science and business issues.

Preferred Qualifications

• Advanced degree (PhD, MS, or equivalent) in life sciences, pharmacy, chemistry, or a related field.
• Experience supporting or preparing for pre-approval inspections (PAI) or commercial GMP inspections by FDA or EMA.
• Experience with electronic QMS platforms (e.g., Veeva QualityDocs, TrackWise, or equivalent).
• Experience in biologics or RNA-based therapeutic development environments.

Pay

Wisconsin pay range: $180,000 USD - $210,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.