Complaint Quality Approver

About Johnson & Johnson

Johnson & Johnson is a global healthcare innovator dedicated to improving health by preventing, treating, and curing complex diseases through cutting-edge solutions in Innovative Medicine and MedTech. Our mission is to create smarter, less invasive treatments and personalized care for a better future in healthcare. Emphasizing diversity, equity, and inclusion as foundational values rooted in Our Credo, we strive to foster an inclusive workplace where every individual is respected and their contributions are valued.

Role Overview

The Complaint Quality Approver plays a critical role within the External Quality group, operating across multiple global locations including Little Island, Cork, Ireland. This position offers independent and impartial review of complaint records ensuring investigations are thorough, scientifically sound, and compliant with all relevant procedures and regulations. The role is primarily virtual but site-based, managing complaint records for products manufactured at the site and harmonizing investigation outcomes across various sites and functions.

Key Responsibilities

• Conduct comprehensive, objective final reviews of complaint records prior to closure.
• Ensure that investigation approaches, root cause analyses, and related evidence meet rigorous quality standards.
• Confirm engagement of all necessary stakeholders and evaluate impacts along the full supply chain.
• Monitor investigation progress, challenge assumptions, and ensure detailed documentation of updates and risk management steps.
• Verify accuracy and integrity of data, adherence to evidence-based conclusions, and adequate assessment of trends or recurrence.
• Coach investigation owners on best practices in CAPA, system utilization, and investigation quality.
• Ensure corrective actions and nonconformities are properly assigned, owned, and tracked before case closure.
• Collaborate effectively with cross-functional teams and global affiliates to align investigation strategies and outcomes.

Professional Knowledge and Skills

• Expertise in complaint handling, quality investigations, and the implementation of corrective and preventive actions within regulated environments.
• Strong familiarity with cGMP, Good Documentation Practices, and pharmaceutical/medical product regulatory expectations internationally.
• Capability to critically review technical documentation such as batch records, test results, and protocols to identify deficiencies or inconsistencies.
• Excellent written communication skills for providing clear, precise approval rationales and feedback.
• Analytical abilities to interpret trends, metrics, and performance data effectively.
• Organizational proficiency enabling independent work and successful management of multiple records under tight deadlines.

Required Qualifications and Experience

• Bachelor's degree in Life Sciences or a related field, or equivalent professional experience.
• Two to four years of relevant experience in quality investigations involving complaints, deviations, or similar events.
• Demonstrated experience within quality systems and knowledge of regulatory and compliance frameworks.
• Ability to produce clear, concise documentation and professional feedback.
• Strong problem-solving, critical thinking, and decision-making capabilities.
• Effective time management and prioritization skills.

Work Environment and Interfaces

• The role requires effective operation within a matrix organizational structure, engaging frequently with local and global leaders.
• Collaboration with complaint investigation owners and interdisciplinary teams including Manufacturing, QC, Engineering, Supply Chain, Packaging, and MSAT specialists.
• Coordination with other sites and affiliates to ensure alignment in investigation strategies and outcomes for site-manufactured product complaints.

Compensation and Benefits

For Ireland, the anticipated salary range is €63,300 to €101,315 annually. Additional benefits include an annual performance-based bonus, various leave provisions including parental leave, bereavement, caregiver, and volunteer leave, wellness reimbursements, and participation in insurance plans for employees and eligible dependents. Recognitions such as service anniversary awards are also offered. Benefit details may vary by location and are subject to change.