Vendor Quality Management Lead

2 weeks ago

San Diego, California, United States Arrowhead Pharmaceuticals Full time

Company Overview

Arrowhead Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing innovative therapies that target intractable diseases through gene silencing. Utilizing advanced RNA chemistries and effective delivery mechanisms, Arrowhead's treatments activate the RNA interference process to achieve significant and lasting reductions in the expression of harmful genes.

Our mission is to create groundbreaking medications for genetically driven diseases, characterized by the excessive production of specific proteins linked to these conditions. The versatility of our RNAi technologies allows us to explore therapeutic opportunities across a wide range of medical areas, including those traditionally challenging to address with conventional small molecules and biologics. Arrowhead is at the forefront of expanding RNAi applications beyond the liver, with a robust clinical pipeline targeting diseases in both the liver and lung, alongside a promising array of preclinical candidates.

Position Summary

The primary objective of this role within the Quality and Compliance division is to oversee and manage all facets of Vendor Quality management initiatives. A critical aspect of this position will be the ongoing development, supervision, and enhancement of the GCP, GLP, GCP, and cGMP (GxP) Vendor Quality program and corporate policies.

This role is integral to the Quality Management Systems Center of Excellence and will collaborate closely with teams across Supply Chain, Legal, Quality, Purchasing, and Commercial departments to foster an understanding of quality and regulatory compliance standards among GxP Vendors, ensuring their adherence to applicable regulatory and contractual obligations.

Key Responsibilities

  • Design and refine a comprehensive vendor quality management program, incorporating risk assessments, performance metrics, and continuous improvement strategies.
  • Oversee the creation and upkeep of quality agreements with vendors, ensuring compliance requirements are clearly defined and met; collaborate with Legal and operational teams to align these agreements with business objectives.
  • Manage GxP Vendor quality governance and compliance by establishing, monitoring, and analyzing vendor quality metrics and key compliance indicators (QKPIs).
  • Prepare and deliver regular reports on compliance status to management, detailing measures and activities undertaken to ensure adherence.
  • Support Quality Review Meetings to discuss trends, issues, or risks related to vendor quality performance.
  • Lead investigations into vendor quality events and supplier corrective action requests, engaging cross-functional teams to ensure thorough completion of risk assessments and implementation of corrective actions.
  • Participate in and lead initiatives aimed at process and quality improvement.
  • Support the Quality Assurance vendor qualification program, including planning and conducting vendor audits.
  • Promote a culture of compliance by developing and distributing training materials that enhance stakeholder awareness of regulatory requirements and industry standards.
  • Perform additional duties as assigned.

Qualifications

  • Bachelor's degree with a minimum of 5 years of relevant experience.
  • In-depth knowledge of GCP/GLP/GvP/GMP regulations and the ability to interpret phase-appropriate requirements.
  • Proficient in Microsoft Office suite.
  • Ability to adhere to company policies and procedures.
  • Strong analytical and problem-solving skills with excellent judgment.
  • Capacity to collaborate effectively across functions and with external partners.
  • Commitment to safety and proper handling of materials and chemicals.
  • Exceptional attention to detail and organizational abilities.
  • Ability to manage multiple tasks and prioritize effectively with minimal supervision.
  • Strong interpersonal, verbal, and written communication skills.

Preferred Qualifications

  • Advanced degree in a relevant field.
  • Experience with electronic document management systems in regulated environments.

Arrowhead offers competitive salaries and a comprehensive benefits package.

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