Job Purpose
The Senior Specialist Drug Product and Device (GxP) provides comprehensive support to Technical Operations and perform essential oversight of Good Manufacturing Pratice (GMP) compliance for Drug Product (DP) and Device vendors. They will manage all Quality-related issues, oversee CAPAs, Change Controls, and handle GMP-related Temperature Excursions and Technical Complaints, collaborating effectively with the rest of the MoonLake Quality team, the Technical Operations team and consultants (where necessary).
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.
Your profile
Education:
Degree in Life Sciences, Engineering, Pharmacy, or a related scientific discipline (or equivalent experience).
Experience:
Experience working in a GxP‑regulated environment (pharmaceutical, biotech, medical device, or clinical research).
Hands‑on experience with complaint handling, quality issues, or deviation management within a Quality Management System.
Familiarity with electronic QMS platforms (e.g., Qualio or similar).
Experience with device or combination product complaints (desirable).
Exposure to temperature excursions, packaging complaints, or technical product issues (desirable).
Experience supporting regulatory inspections or audits (desirable).
Skills/knowledge/behavioural competencies:
Strong understanding of GxP principles and quality system processes.
Excellent documentation and technical writing skills.
Ability to manage multiple complaints simultaneously while meeting regulatory timelines.
Strong attention to detail and a structured, risk‑based approach to problem solving.
Effective communication and stakeholder‑management skills.
Work Location:
2 days a week in our brand new Porto or Cambridge office
Why us?
An exciting job opportunity awaits you!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
What we offer:
Learning Environment:
An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work:
Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance:
Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth:
A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science:
We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We go beyond:
We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value:
We aspire to create long-term value for investors and communities.