The PositionThe Senior Quality Specialist, Supplier Quality is responsible for ensuring that suppliers and contract manufacturers meet quality, regulatory, and compliance requirements. This role supports all aspects of qualification, monitoring, and continuous improvement of suppliers, contract manufacturers (CMOs), contract testing laboratories, and material suppliers supporting pharmaceutical development and commercialization. The candidate will be expected to interact with multiple internal departments and external vendors.
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.
- Support the performance of cross-functional assessments of SCARs and SCNs, evaluating impact and ensuring appropriate action plans and effectiveness checks are established, as needed.
- Perform quality agreement lifecycle management, including but not limited to, drafting, editing, reviewing, approving, and ensuring compliance with periodic review cycles.
- Assist 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.
- Other duties consistent with the position as assigned from time to time
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.
- CSQP certification.
- Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office suite, DocuSign, and SmartSheet.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to consistently communicate with external parties in a professional manner.
- Ability to follow company procedures, work instructions, and policies.
- Excellent attention to detail and organizational skills.
- Ability to work independently with minimal supervision as well as manage priorities within a fast-paced environment.
Wisconsin pay range
$90,000-$110,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
