GCP Quality Lead Manager – Hybrid (Porto)

Moonlake; Porto; Hybride; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Learning Environment

Flexibility and Balance

Career Growth

Résumé du poste

MoonLake Immunotherapeutics in Porto, Portugal seeks a Manager Quality (GCP) on a fixed-term contract to lead GCP quality oversight across clinical programmes and support audits, CAPAs and inspections readiness. You will collaborate with CROs and internal teams to ensure trials meet regulatory standards.

Key responsibilities include maintaining the QMS, monitoring quality metrics, and providing guidance on risk management and quality issues to study teams.

Qualifications

• Experience managing quality issues and CAPAs in biotech/biopharma.
• Proven track record monitoring GCP compliance within biotech/biopharma companies.
• Experience conducting GCP clinical audits as lead or support auditor (investigator site audits, GCP vendor audits, process/system audits).
• Experience quality oversight of clinical trials from protocol development to clinical study reporting.

Responsabilités

• Provide GCP quality oversight and support for clinical trials and vendors.
• Lead CAPA processes and ensure CAPA effectiveness.
• Conduct internal and external GCP and GCLP audits as lead or support auditor.
• Support inspection readiness activities and regulatory inspections.
• Maintain and monitor the QMS to ensure regulatory compliance.
• Develop and report quality metrics and dashboards to senior management.

Connaissances

GCP knowledge

Audit processes

Regulatory guidelines

Communication skills

Risk management

Analytical thinking

Organisational skills

Collaborative work

Formation

Bachelor’s degree in life science or healthcare

Outils

GxP Quality Management System

Quality management software

Audit tools

Description du poste

MoonLake Immunotherapeutics in Porto, Portugal seeks a Manager Quality (GCP) on a fixed-term contract to lead GCP quality oversight across clinical programmes and support audits, CAPAs and inspections readiness. You will collaborate with CROs and internal teams to ensure trials meet regulatory standards.

Key responsibilities include maintaining the QMS, monitoring quality metrics, and providing guidance on risk management and quality issues to study teams.