Senior Quality Specialist, CAPA Investigations

Arrowhead Pharmaceuticals•Verona, WI

6h•$90,000 - $110,000

About The Position

Serve as a senior contributor to Arrowhead’s Corrective and Preventive Action (CAPA) program within the Quality Management System (QMS), facilitating and executing CAPA and investigation activities that support ongoing development and commercial programs. Provide oversight of CAPA record processing, root cause analysis, and effectiveness checks to ensure timely, compliant, quality-driven resolution of quality events. Partner with cross-functional teams and subject matter experts to investigate root causes, implement appropriate corrective and preventive actions, and close CAPAs in alignment with regulatory requirements and quality goals. The role also supports CAPA governance, metrics and reporting, training, quality systems, audits, inspections, and continuous improvement. The position is based in Wisconsin, and the stated salary range is $90,000–$110,000 USD. Candidates must have current, valid authorization to work in the country where the role is located.

Requirements

Bachelor’s degree in engineering, life sciences, or a related scientific field, or an equivalent combination of education and experience.
At least five years of experience in a regulated pharmaceutical, biotech, or medical-device environment, with demonstrated CAPA, quality assurance, or quality engineering experience.
Demonstrated use of quality tools and methodologies, such as Six Sigma, root cause analysis, and 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 organizational levels.
Strong organizational and follow-up skills, including the ability to multitask, prioritize, and meet deadlines in a fast-paced environment.
Competency with Microsoft Word, Excel, and Smartsheet.
Current, valid authorization to work in the country where the role is located.

Nice To Haves

Six Sigma root cause analysis/problem-solving training and experience.
Ability to work independently and manage priorities in a fast-paced environment.
Demonstrated ability to coordinate cross-functional activities and drive tasks to completion.
Experience with quality systems supporting GxP regulations, including 21 CFR Parts 11, 210, and 211, QMSR, and EU requirements.
Prior experience using an electronic document and quality management system in a regulated environment.

Responsibilities

Participate in or lead CAPA projects, ensuring records are completed with appropriate quality, compliance, and timeliness.
Lead investigations into quality events, gather relevant data, and perform preliminary root cause analysis using structured problem-solving methods such as Six Sigma, 5 Whys, and fishbone analysis.
Partner with subject matter experts to thoroughly investigate root causes, assess product impact to Safety, Identity, Strength, Purity, and Quality (SISPQ), and identify appropriate corrective and preventive actions.
Establish 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 before CAPA closure and conduct effectiveness checks for high-risk CAPAs.
Coordinate and support CAPA Quality Review Board (QRB) meetings, including preparing agendas and minutes and tracking follow-up action items through closure.
Communicate CAPA and investigation metrics, trends, and escalations to management and key stakeholders clearly and promptly.
Contribute to trend-review reporting and lifecycle-review activities to help identify and resolve process shifts and emerging trends.
Compile and prepare CAPA and investigation metrics and reports routinely in accordance with established procedures.
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 expertise on CAPA and investigation records.
Maintain CAPA and investigation documentation in accordance with internal procedures and applicable regulatory requirements.
Collaborate with cross-functional teams on continuous-improvement initiatives and projects related to the CAPA program.
Support communication and teamwork within Quality Assurance and related departments.
Communicate effectively with management, peers, and 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.