Senior Quality Specialist, Supplier Quality

Responsibilities

• Manage the SCARs and Supplier Change Notification Programs and ensure effective and timely assessment and resolution of the proposed changes.
• Guide and coach key stakeholders on SCAR and SCN processes to promote consistency and drive quality culture.
• Perform quality agreement lifecycle management, including but not limited to, drafting, editing, reviewing, approving, and ensuring compliance with periodic review cycles.
• Affiliate in establishing, implementing, and monitoring Supplier KPIs (key performance indicators) and actively contribute to the internal Quality Management Review and external Business Review meetings.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Write, review, update, approve, issue, and organize applicable Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, etc.).
• Support regulatory inspections by serving as a subject matter expert.
• Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.

Requirements

• Bachelor's degree in science field.
• Minimum of 8 years of experience in pharmaceutical or biotechnology quality, with 4+ years in supplier quality.
• Strong working knowledge of FDA, EMA, ICH, GxP, and GDP regulations.
• Excellent communication skills and ability to work with diverse professionals.
• A detail-oriented self-starter who proactively anticipates and resolves challenges while continuously seeking opportunities to expand their role and contribute to Arrowhead's success.

Preferred

• Prior experience with use of an electronic document management system in a regulated environment.
• CSCQP certification.
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office suite, DocuSign, and SmartSheet.

Benefits

Wisconsin pay range: $90,000 USD - $110,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.