Senior Specialist, Quality Assurance
Arrowhead Pharmaceuticals
July 02, 2026
Remote friendly (Madison, WI)
United States
Operations
Responsibilities:
- Oversee raw material lifecycle management, including authoring, reviewing, and providing final SQA approvals for material specifications and qualification protocols/reports; ensure materials meet periodic requalification requirements.
- Initiate and assess change controls for impact to material supplier quality management, process impact, and patient safety.
- Request, collect, and review supporting technical documentation (e.g., manufacturing production records, CoAs, CoCs, BSE/TSE statements) to support GMP manufacturing and material lifecycle management.
- Lead risk-based material evaluation (material criticality assessments and formal quality risk assessments) and ensure results inform qualification requirements and supplier controls.
- Oversee supplier quality events/non-conformances; investigate and resolve issues with suppliers and internal stakeholders; oversee Supplier Corrective Action Requests (SCARs) including initiation, review, and approval per procedures and quality agreements.
- Monitor/analyze/report supplier quality performance metrics (e.g., SCAR rates) and drive continuous improvement and/or supplier business reviews.
- Author, update, and review Quality System documents (SOPs, work instructions, forms) related to supplier quality and materials.
- Perform other related Quality Assurance and Supplier Quality duties as assigned.
Requirements:
- Bachelor’s degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology) or equivalent education/experience.
- 8+ years of QA experience in a GMP-regulated biotech/pharmaceutical organization with significant supplier/material quality experience.
- Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance.
- Strong quality focus, attention to detail, time management, and organizational skills.
- Ability to communicate professionally with external suppliers.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Proficiency with Adobe Acrobat, Microsoft Office, DocuSign, and SmartSheet.
- Excellent interpersonal, verbal, and written communication skills; ability to follow procedures and work independently while managing priorities in a fast-paced environment.
Benefits:
- Competitive salaries and an excellent benefit package.
Compensation:
- Wisconsin pay range: $90,000 USD - $110,000 USD
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.
- Oversee raw material lifecycle management, including authoring, reviewing, and providing final SQA approvals for material specifications and qualification protocols/reports; ensure materials meet periodic requalification requirements.
- Initiate and assess change controls for impact to material supplier quality management, process impact, and patient safety.
- Request, collect, and review supporting technical documentation (e.g., manufacturing production records, CoAs, CoCs, BSE/TSE statements) to support GMP manufacturing and material lifecycle management.
- Lead risk-based material evaluation (material criticality assessments and formal quality risk assessments) and ensure results inform qualification requirements and supplier controls.
- Oversee supplier quality events/non-conformances; investigate and resolve issues with suppliers and internal stakeholders; oversee Supplier Corrective Action Requests (SCARs) including initiation, review, and approval per procedures and quality agreements.
- Monitor/analyze/report supplier quality performance metrics (e.g., SCAR rates) and drive continuous improvement and/or supplier business reviews.
- Author, update, and review Quality System documents (SOPs, work instructions, forms) related to supplier quality and materials.
- Perform other related Quality Assurance and Supplier Quality duties as assigned.
Requirements:
- Bachelor’s degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology) or equivalent education/experience.
- 8+ years of QA experience in a GMP-regulated biotech/pharmaceutical organization with significant supplier/material quality experience.
- Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance.
- Strong quality focus, attention to detail, time management, and organizational skills.
- Ability to communicate professionally with external suppliers.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Proficiency with Adobe Acrobat, Microsoft Office, DocuSign, and SmartSheet.
- Excellent interpersonal, verbal, and written communication skills; ability to follow procedures and work independently while managing priorities in a fast-paced environment.
Benefits:
- Competitive salaries and an excellent benefit package.
Compensation:
- Wisconsin pay range: $90,000 USD - $110,000 USD
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.