Arrowhead Pharmaceuticals

Director, Quality Management Systems

Verona, Wisconsin, United States · Director

Sponsorship not specified$180k-$210kDetected 16 days ago

ComplianceSupply ChainGMPFDA RegulatoryMedical DevicesResearchAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingGxPRegulatory Affairs

About the role

You will report directly to the VP of Quality, operate with real authority, and leave a mark on how quality works at Arrowhead for years to come.

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
Lead and support risk assessments using current industry best practices and methodologies.
Partner with manufacturing, analytical development and quality control, supply chain, regulatory affairs, manufacturing, and clinical and non-clinical development teams to ensure alignment on quality and compliance objectives.
Build, mentor, and lead a high-performing QMS team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
Strong leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.
Perform additional duties as requested

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

Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
Arrowhead Pharmaceuticals is at an inflection point.

We are advancing a broad pipeline of RNA-based therapies toward commercial readiness - and we are building and enhancing the quality infrastructure to match.

This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.