Vendor Compliance Officer

6 days ago

San Diego, California, United States Arrowhead Pharmaceuticals Full time

About the Role

The Quality Management Specialist will play a critical role in ensuring the quality and compliance of Arrowhead Pharmaceuticals' vendor management program. This position will be responsible for developing and maintaining comprehensive vendor quality management processes, including risk assessment, performance metrics, and continuous improvement.

Key Responsibilities

  • Develop and optimize vendor quality management program and processes to ensure compliance with regulatory requirements and industry standards.
  • Manage the development and maintenance of quality agreements with vendors to ensure clear expectations and compliance requirements are met.
  • Oversee vendor quality governance and compliance management by establishing, tracking, trending, and analyzing vendor quality metrics and key performance indicators.
  • Prepare and present periodic reports and status of compliance to management, including measures and activities to ensure compliance.
  • Support functional and corporate Quality Review Meetings to communicate trends, issues, or risks related to vendor quality performance.
  • Lead investigations into vendor quality events and supplier corrective actions requests through engagement with cross-functional staff to ensure effective completion of required risk and impact assessments and implementation of corrective and preventive actions.
  • Lead and/or participate in process/quality improvement initiatives to enhance vendor quality management processes.
  • Support Quality Assurance vendor qualification program, including planning, participation, and follow-up of vendor audits.
  • Proactively drive a culture of compliance by drafting and disseminating written materials and training aimed at increasing stakeholders' awareness and understanding of relevant regulatory requirements and industry standards.

Requirements

  • Bachelor's degree and at least 5 years of relevant experience in quality management, regulatory affairs, or a related field.
  • Strong knowledge of GCP/GLP/GxP/GMP and relevant Federal, State, and international regulations, with the ability to determine phase-appropriate requirements.
  • Competent knowledge of and ability to use Microsoft Office suite.
  • Ability to follow company procedures, work instructions, and policies.
  • Ability to process, synthesize, and summarize complex issues.
  • Excellent judgment, analytical, and problem-solving skills.
  • Ability to work collaboratively across functions and with external partners.
  • Work in a safe manner; properly handle materials and chemicals.
  • Excellent attention to detail and organizational skills.
  • Ability to multi-task and prioritize work tasks with minimal supervision.
  • Excellent interpersonal, verbal, and written communication skills.

Preferred Qualifications

  • Advanced degree in a relevant area.
  • Prior experience with the use of an electronic document management system in a regulated environment.

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