Senior Quality Specialist, CAPA Investigations

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.