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 focused on developing innovative therapies that target challenging diseases through gene silencing. Our approach utilizes advanced RNA chemistries and effective delivery methods to activate the RNA interference (RNAi) mechanism, resulting in significant and lasting reductions in the expression of harmful genes.

Our mission is to create groundbreaking treatments for genetic disorders characterized by the excessive production of specific proteins. With our versatile RNAi technologies, we aim to tackle a wide range of therapeutic areas and pursue targets that are often unreachable by conventional small molecules and biologics. Arrowhead is at the forefront of applying RNAi technology to address diseases beyond the liver, with a robust clinical pipeline that includes promising preclinical candidates.

Role Summary

The Director of Quality for Combination Products will play a critical role within the Quality and Compliance department, providing leadership and oversight for the development and management of medical device and drug combination products.

This position will report directly to the Vice President of Quality and Compliance and will collaborate closely with teams across Operations, Supply Chain, Regulatory Affairs, Quality Assurance, and Commercial sectors, as well as with external partners and suppliers. The focus will be on supporting the Quality Management System (QMS) and ensuring compliance with relevant regulations while aligning with the strategic objectives of the organization.

Key Responsibilities

  • Act as the primary subject matter expert for combination products, leading all quality-related aspects of the QMS and product development.
  • Guide and ensure that all internal stakeholders' decisions and actions adhere to current Good Manufacturing Practices (cGMPs), Quality System Regulations (QSR), ISO 13485, and applicable international standards.
  • Develop and uphold a comprehensive quality strategy, providing guidance to engineering teams throughout design control, risk management, human factors engineering, process development, verification and validation testing, packaging, and distribution.
  • Establish and maintain essential documentation, including the Design History File (DHF) and Device Master File (DMF), relevant to the combination product QMS.
  • Promote continuous improvement initiatives within the combination product QMS, identifying areas for enhancement and ensuring effective remediation.
  • Support the development and management of Quality Agreements, conduct external audits of suppliers, and facilitate third-party assessments within the Supply Chain.
  • Assist with internal audits, certifications, and regulatory inspections for Arrowhead and its suppliers.
  • Prepare and deliver regular reports to management regarding the regulatory compliance status of combination products, QMS, and DMF, including ongoing compliance measures and activities.
  • Perform additional duties as assigned.

Qualifications

  • Bachelor's degree in a relevant scientific or engineering discipline, with a minimum of 8 years of pertinent experience.
  • In-depth knowledge of FDA regulations (21 CFR Part 820, 21 CFR Parts 210/211), ISO 13485, and other relevant international standards.
  • Proven experience in leading QMS implementation, maintenance, and improvement initiatives, including Corrective and Preventive Actions (CAPA), change control, and risk management processes.
  • Experience in liaising with regulatory authorities.
  • Proficient in Microsoft Office applications.
  • Prior experience with electronic document management systems in regulated environments.
  • Ability to adhere to company policies, procedures, and work instructions.
  • Strong analytical and problem-solving skills, with excellent judgment.
  • Commitment to safety and proper handling of materials and chemicals.
  • Exceptional attention to detail and organizational capabilities.
  • Ability to manage multiple tasks and prioritize effectively with minimal supervision.
  • Outstanding interpersonal, verbal, and written communication skills.

Preferred Qualifications

  • Master's degree in a relevant field.
  • Relevant professional certification.

Arrowhead offers competitive salaries and a comprehensive benefits package.

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