GCP Quality Lead for Clinical Trials & Audits

MoonLake Immunotherapeutics; Porto; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Learning environment

Impactful work

Flexible work arrangement

Career growth

Job summary

MoonLake Immunotherapeutics is seeking a Manager Quality (GCP) to ensure robust GCP compliance across its clinical development programmes. You will lead audits, manage CAPAs, and support inspections readiness while partnering with clinical teams and CROs to maintain high regulatory standards.

The role involves quality oversight of trials from protocol to reporting, maintaining the QMS, and developing metrics for Quality performance. The position offers hybrid work with Porto office presence.

Qualifications

• Experience managing quality issues and CAPAs in biotech/biopharma.
• Proven track record monitoring GCP compliance in biotech/biopharma.
• Conducting GCP audits as lead or support auditor.
• Experience with quality oversight of clinical trials from protocol to reporting.

Responsibilities

• Provide GCP quality oversight across MoonLake’s clinical trials and vendors.
• Lead and support audits and inspections readiness activities.
• Manage CAPAs and quality risk management for assigned programmes.
• Maintain QMS and ensure regulatory compliance.
• Report progress and risks to the Director, GCP.

Skills

GCP knowledge

Audit management

Regulatory knowledge

Risk management

Quality oversight

Stakeholder comms

Education

Bachelor's in life sciences

Job description

MoonLake Immunotherapeutics is seeking a Manager Quality (GCP) to ensure robust GCP compliance across its clinical development programmes. You will lead audits, manage CAPAs, and support inspections readiness while partnering with clinical teams and CROs to maintain high regulatory standards.

The role involves quality oversight of trials from protocol to reporting, maintaining the QMS, and developing metrics for Quality performance. The position offers hybrid work with Porto office presence.