Complaint Quality Approver

About Johnson & Johnson

Johnson & Johnson is a global leader in healthcare innovation dedicated to preventing, treating, and curing complex diseases through smarter, less invasive treatments and personalized solutions. The organization operates across Innovative Medicine and MedTech sectors, aiming to improve health for humanity worldwide. Committed to diversity, equity, and inclusion, Johnson & Johnson fosters a respectful and inclusive work culture where every employee's unique value is recognized.

Role Overview

The Complaint Quality Approver position within the External Quality group involves independently reviewing and approving complaint records to guarantee thorough, scientifically valid, and regulation-compliant investigations. This role ensures risk assessment, evidence-backed root cause analysis, stakeholder involvement, and clear resolution documentation. The position supports virtual site-based complaint approvals across multiple global locations, emphasizing alignment of investigation strategy and outcomes across sites and functions.

Primary Responsibilities

• Deliver independent quality reviews and final approval for complaint records before closure.
• Ensure investigation strategies, root cause analyses, and supporting evidence are comprehensive and appropriate.
• Confirm inclusion of relevant stakeholders and evaluate supply chain impacts where applicable.
• Monitor investigation progress, address any gaps, and validate accurate documentation of new findings and actions.
• Identify, manage, and escalate risks as necessary.
• Verify data integrity and ensure conclusions are supported by objective evidence.
• Assess trending, recurrence, and cross-site or affiliate alignment.
• Provide coaching on CAPA best practices, system usage, and investigation quality.
• Ensure all necessary actions and nonconformities are assigned, tracked, and completed before closing records.

Collaborations

• Operate effectively within a matrixed organization, engaging with local and global cross-functional leaders.
• Work alongside complaint investigation owners and teams from functions such as Manufacturing, Quality Control, Engineering, Supply Chain, Packaging, and MSAT.
• Coordinate with other global sites and affiliates to harmonize investigation strategies and results for site-manufactured product complaints.

Qualifications and Skills

• Bachelor's degree in Life Sciences or related field, or equivalent experience.
• At least 2 to 4 years of experience in performing or reviewing quality investigations, including complaints, deviations, or nonconformances.
• Familiarity with quality systems, regulatory requirements, and compliance standards.
• Strong technical document review skills for batch records, test data, protocols, and procedures, identifying inconsistencies or gaps.
• Proficient written communication to provide clear approval rationales and constructive feedback.
• Analytical capabilities to interpret trends and performance metrics accurately.
• Ability to work independently and collaboratively, with sound organization and time management abilities.

Preferred Skills

• Understanding of business alignment and savvy.
• Coaching and continuous improvement capabilities.
• Knowledge of compliance management and regulatory environments.
• Expertise in quality control, quality management systems, ISO 9001 standards, SOP adherence, and issue escalation.
• Problem-solving and fact-based decision-making proficiency.

Additional Information

This position is available at multiple locations globally and listed under various requisition numbers. Candidates are advised to apply for preferred locations aligned with their choices. The salary range for the role in Ireland is approximately €63,300 to €101,315 annually, and in Belgium €72,500 to €115,230 annually. Benefits include annual bonuses based on performance, paid leave including parental and volunteer leave, wellbeing reimbursements, financial and health programs, and recognition awards. These offerings may vary by location and are subject to change.