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Quality Manager, Vendor Oversight
2 months ago
We are seeking a highly skilled Quality Manager to oversee all aspects of Vendor Quality management activities within our Quality and Compliance department. This role will involve developing and maintaining comprehensive vendor quality management programs, ensuring compliance with regulatory requirements, and promoting a culture of quality and regulatory compliance across our GxP vendors.
Key Responsibilities- Develop and optimize vendor quality management programs, including risk assessment, performance metrics, and continuous improvement
- Manage quality agreements with vendors, ensuring clear expectations and compliance requirements are met
- Oversee GxP vendor quality governance and compliance management, including tracking and analyzing vendor quality metrics and key compliance indicators
- Prepare and present periodic reports on compliance status to management
- Support 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
- Support Quality Assurance vendor qualification program, including planning and participation in vendor audits
- BS degree and at least 5 years of relevant experience
- Strong knowledge of GCP/GLP/GxP/GMP regulations and ability to determine phase-appropriate requirements
- Competent knowledge of Microsoft Office suite and ability to use it effectively
- Excellent judgment, analytical, and problem-solving skills
- Ability to work collaboratively across functions and with external partners
- Excellent attention to detail and organizational skills
- Ability to multi-task and prioritize work tasks with minimal supervision
- Advanced degree in relevant area
- Prior experience with electronic document management systems in a regulated environment
Arrowhead Pharmaceuticals offers competitive salaries and an excellent benefit package. We are an equal opportunity employer and welcome applications from diverse candidates. All applicants must have authorization to work in the US for a company.