Senior Specialist, Quality Assurance

Responsibilities

• Oversee raw material lifecycle management activities, including authoring, reviewing, and providing final SQA approvals for material specifications and qualification protocols/reports, and ensuring all materials remain in compliance with periodic requalification requirements.
• Initiate and assess change controls for impact to material supplier quality management, process impact, and patient safety.
• Ensure that all necessary supporting material technical documentation (e.g. manufacturing production records, CoAs, CoCs, BSE/TSE statements) are properly requested, collected, and reviewed to support GMP manufacturing activities and material lifecycle management.
• Lead risk-based material evaluation processes, including conducting material criticality assessments and formal quality risk assessments for materials and suppliers. Ensure risk evaluations inform qualification requirements and supplier control strategies.
• Provide oversight for supplier-related quality events and non-conformances, partnering with suppliers and internal stakeholders to investigate and resolve issues (e.g. documentation discrepancies, material non-conformances).
• Oversee Supplier Corrective Action Request (SCAR) execution, including initiating, reviewing, and approving material SCARs in accordance with Arrowhead procedures and the applicable quality agreements.
• Monitor, analyze, and report material supplier quality performance metrics (e.g. SCAR rates) and drive continuous improvement initiatives or supplier business reviews based on data insights.
• Author, update, and review Quality System documents (SOPs, work instructions, forms) as related to supplier quality and materials.

Requirements

• Bachelor’s degree in an applicable scientific field (e.g. Chemistry, Biochemistry, Biotechnology), or equivalent combination of related education and experience.
• Minimum of eight years of quality assurance experience in a GMP-regulated biotechnology or pharmaceutical organization, with significant experience in supplier and material quality processes.
• Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents.
• Strong focus on quality and attention to detail as well as effective time management and organizational skills.
• Ability to consistently communicate with external suppliers in a professional manner.

Preferred

• Prior experience with use of an electronic document management system in a regulated environment.
• Certified in relevant quality systems (e.g., ISO 9001, ISO 13485).
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, DocuSign, and SmartSheet.

Benefits

Wisconsin pay range: $90,000 USD - $110,000 USD
Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located.

Contact Information

Candidates must have current, valid authorization to work in the country where this role is located.
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