Senior Quality Specialist, CAPA Investigations

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

Serve as a senior contributor to the Corrective and Preventive Action (CAPA) program within the Quality Management System (QMS), facilitating and executing CAPA and investigation activities to support ongoing development and commercial programs at Arrowhead. Provide oversight of CAPA record processing, root cause analysis, and effectiveness checks to ensure timely, compliant, and quality-driven resolution of quality events. Partner with cross-functional teams and subject matter experts to ensure root causes are thoroughly investigated, corrective and preventive actions are appropriately implemented, and CAPAs are closed in alignment with regulatory requirements and quality goals.

Responsibilities

CAPA and Investigation Execution

• Participate in or lead CAPA projects, ensuring records are completed with appropriate quality, compliance, and timeliness.

• Lead investigation into quality events, gather relevant data, and perform preliminary root cause analysis using structured problem-solving methodologies, such as Six Sigma, 5 Whys, and fishbone analysis.

• Partner with subject matter experts to ensure root causes are thoroughly investigated, product impact to Safety, Identity, Strength, Purity, and Quality (SISPQ) is assessed, and appropriate corrective and preventive actions are identified.

• Establish appropriate CAPA ownership and timelines based on the risk associated with the event or issue.

• Process CAPA requests by assigning owners and supporting timely responses and approvals in alignment with quality goals.

• Assess final supporting documentation for adequacy prior to CAPA closure and conduct effectiveness checks for high-risk CAPAs.

Communication, Metrics, and Governance

• Coordinate and support CAPA Quality Review Board (QRB) meetings, including agenda preparation, meeting minutes, and tracking follow-up action items to closure.

• Communicate CAPA and investigation metrics, trends, and escalations to management and key stakeholders in a clear and timely manner.

• Provide input to trend review reporting and lifecycle review activities to support identification and resolution of process shifts and emerging trends.

• Compile and prepare CAPA and investigation metrics and reports on a routine basis in accordance with established procedures.

Training, Systems, and Inspection Support

• Serve as a subject matter expert and trainer for the electronic CAPA/investigation module and support delivery of the CAPA training program.

• Support internal audits and regulatory inspections by providing subject matter expertise on CAPA and investigation records.

• Ensure CAPA and investigation documentation is maintained in accordance with internal procedures and applicable regulatory requirements.

Cross-Functional Collaboration and Compliance

• Collaborate with cross-functional teams to support continuous improvement initiatives and projects related to the CAPA program.

• Support an environment that promotes communication and teamwork within Quality Assurance and related departments.

• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.

• Comply with FDA regulations, other applicable regulatory requirements, company policies, procedures, and assigned tasks.

• Perform additional duties as assigned.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related scientific field, or equivalent combination of education and experience.

• Minimum of five (5) years of experience in a regulated environment (pharmaceutical, biotech, or medical device), with demonstrated CAPA, quality assurance, or quality engineering experience.

• Demonstrated use of quality tools and methodologies (e.g., Six Sigma, root cause analysis, structured problem solving).

• Working knowledge of FDA, EU, and ICH GxP regulations and guidance.

• Demonstrated project management and leadership skills, including the ability to lead multi-departmental teams and resolve quality-related issues in a timely, effective manner.

• Strong verbal and written communication skills, with the ability to communicate effectively at multiple levels of the organization.

• Strong organizational and follow-up skills, with the ability to multitask, prioritize, and meet deadlines in a fast-paced environment.

• Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.

Preferred

• Six Sigma root cause analysis/problem-solving training and experience.

• Ability to work independently and manage priorities within a fast-paced environment.

• Demonstrated ability to coordinate cross-functional activities and drive tasks to completion.

• Experience with quality systems supporting GxP regulations (21 CFR Parts 11, 210, 211, QMSR, and EU).

• Prior experience with use of an electronic document and quality management system in a regulated environment.

Wisconsin pay range
$90,000 — $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.

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