Senior Quality Specialist, Supplier Quality

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Senior Quality Specialist, Supplier Quality to ensure suppliers and contract manufacturers meet quality, regulatory, and compliance standards.

You will lead qualification, monitoring, and continuous improvement activities for suppliers, CMOs, and testing labs, interfacing with multiple internal teams and external vendors.

Qualifications

• Minimum of 8 years in pharmaceutical/biotech quality with 4+ years in supplier quality.
• Strong knowledge of FDA, EMA, ICH, GxP and GDP regulations.
• Excellent communication skills and ability to work with diverse professionals.
• Detail-oriented self-starter who proactively resolves challenges and expands role.

Responsibilities

• Manage SCARs and Supplier Change Notification programs and drive timely resolution.
• Guide stakeholders on SCAR/SCN processes to promote quality culture.
• Support cross-functional assessments of SCARs/SCNs and action plans and effectiveness checks.
• Perform quality agreement lifecycle management, including drafting, editing, reviewing, and periodic reviews.
• Assist in establishing, implementing, and monitoring Supplier KPIs and contribute to Quality Reviews.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Write, review, update, approve, issue, and organize applicable SOPs, Wis, test methods, policies, forms, etc.
• Support regulatory inspections as a subject matter expert.
• Operate in compliance with cGMP, 21 CFR, USP, EP and ICH requirements.
• Other duties consistent with the position as assigned.

Skills

Supplier quality

Quality assurance

Regulatory knowledge

Communication skills

Education

Bachelor's degree in science field

Tools

Adobe Acrobat

Microsoft Office

DocuSign

SmartSheet

Electronic document management system

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The 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

• Managethe 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.

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.