Head of Quality for Combination Products

2 weeks ago

Verona, Wisconsin, United States Arrowhead Pharmaceuticals Full time
Position Overview

Arrowhead Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization dedicated to the development of innovative therapies targeting challenging diseases through gene silencing techniques. Our advanced RNA interference (RNAi) technologies facilitate the effective modulation of gene expression, offering potential solutions for various medical conditions.

Role Summary

The Director of Combinational Product Quality will play a critical role within the Quality and Compliance division, overseeing the quality assurance processes for medical device and drug combination products. This leadership position is essential for ensuring that our products meet the highest standards of quality and regulatory compliance.

Key Responsibilities

  • Act as the primary authority on combinational products, leading all quality management system (QMS) initiatives related to product development and oversight.
  • Ensure that all internal operations align with current Good Manufacturing Practices (cGMPs), Quality System Regulations (QSR), ISO 13485, and applicable international guidelines.
  • Develop and implement comprehensive quality strategies, providing guidance throughout the product lifecycle, including design control, risk management, and validation processes.
  • Maintain and oversee the electronic Design History File (DHF) and Device Master File (DMF) pertinent to combinational products.
  • Drive continuous improvement initiatives within the QMS, identifying opportunities for enhancement and ensuring effective remediation.
  • Facilitate the creation and management of Quality Agreements and support external audits of suppliers and third-party vendors.
  • Coordinate internal audits and regulatory inspections, ensuring compliance across all operational facets.
  • Prepare detailed reports for management regarding the status of regulatory compliance and QMS performance.
  • Perform additional duties as required.

Qualifications

  • Bachelor's degree in a relevant scientific or engineering field, with a minimum of 8 years of pertinent experience.
  • In-depth knowledge of FDA regulations, ISO standards, and international compliance requirements.
  • Proven experience in leading QMS initiatives, including corrective and preventive actions (CAPA) and risk management.
  • Strong interpersonal and communication skills, with the ability to engage effectively with regulatory bodies.
  • Proficiency in Microsoft Office and experience with electronic document management systems in regulated environments.
  • Exceptional analytical and problem-solving abilities, with a keen attention to detail.
  • Capacity to manage multiple priorities with minimal supervision.

Preferred Qualifications

  • Master's degree in a relevant field.
  • Professional certifications related to quality management.

Arrowhead Pharmaceuticals offers competitive compensation and a comprehensive benefits package.

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