This role is responsible for the receipt, assessment, investigation, documentation, and closure of technical complaints in accordance with GxP regulations (including GMP, GCP, and GDP, as applicable). The role ensures that all technical complaints, such as device issues, temperature excursions, packaging defects, or product quality concerns, are managed in compliance with internal procedures and regulatory expectations and are appropriately recorded, investigated, trended, and reported within the electronic Quality Management System (eQMS).
This role supports patient safety, product quality, and regulatory compliance across clinical and commercial activities.
Key Accountabilities:
- Technical Complaint Management
- Act as the primary coordinator for technical complaints, ensuring complaints are logged, assessed, investigated, and closed within defined timelines using the eQMS (e.g., Qualio).
- Ensure accurate completion of complaint records, including complaint details, product information, batch/lot numbers, and classification
- Perform initial assessment and classification of complaints (e.g., technical vs safety‑related) and ensure appropriate escalation when required
- Investigation & Root Cause Analysis
- Coordinate and document complaint investigations, working with internal stakeholders and external vendors as required.
- Support or lead root cause analysis, ensuring conclusions are evidence‑based and adequately justified.
- Ensure CAPAs, change controls, or quality issues are raised and tracked where required following investigation outcomes.
- GxP Compliance & Documentation
- Ensure all complaint handling activities comply with applicable GxP regulations, internal SOPs, and Quality Management System requirements.
- Maintain inspection‑ready documentation, ensuring complaint records are complete, traceable, and auditable.
- Support internal and external audits and inspections by providing complaint data, metrics, and documentation as required
- Work with the MoonLake Quality Team to manage and develop Quality Systems and procedures within the company
- Cross‑Functional Collaboration
- Liaise with Clinical Operations, Technical Operations, Quality Assurance, Pharmacovigilance, and external vendors/CDMOs to support timely resolution and Drug Product / Device assembly, labelling and packaging activities, including complaints.
- Support alignment between technical complaints and related quality processes such as deviations, recalls, and serious breaches, where applicable.
- Work with the Drug-Device Development Team to define and oversee activities sub contracted to vendors by MoonLake, with specific emphasis on quality and compliance requirements
- Trending & Reporting
- Support trend analysis of technical complaints, contributing to periodic quality reports and management review activities.
- Identify recurring issues and contribute to continuous improvement initiatives within the Quality System.