Senior Quality Manager, Vendor Compliance
4 weeks ago
Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. We are seeking a Senior Quality Manager, Vendor Compliance to join our Quality and Compliance department.
The purpose of this position is to manage and oversee all aspects of Vendor Quality management activities, including the development, maintenance, and monitoring of the GCP, GLP, GxP, and cGMP Vendor Quality program and corporate policies.
This role will work closely with members of the Supply Chain, Legal, Quality, Purchasing, and Commercial teams to promote awareness of quality and regulatory compliance standards across GxP Vendors and ensure their adherence to relevant regulatory and contractual obligations.
Responsibilities include:
- Developing and optimizing comprehensive vendor quality management programs and processes
- Managing quality agreements with vendors to ensure clear expectations and compliance requirements are met
- Overseeing GxP Vendor quality governance and compliance management
- Preparing and presenting periodic reports on compliance status
- Supporting functional and corporate Quality Review Meetings
- Leading investigations into vendor quality events and supplier corrective actions requests
- Participating in process/quality improvement initiatives
- Supporting Quality Assurance vendor qualification programs
Requirements include a BS degree and at least 5 years of relevant experience, as well as strong knowledge of GCP/GLP/GxP/GMP and relevant Federal, State, and international regulations.
Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company.
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