GCP Quality Lead - Clinical Trials

MoonLake Immunotherapeutics; Pedrouços; Híbrido; EUR 70 000 - 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model

Learning environment

Career growth

Resumo da oferta

MoonLake Immunotherapeutics is seeking a Manager Quality (GCP) to ensure robust GCP compliance across clinical development programs. You will lead audits, manage quality risks, and support inspections readiness while guiding trial teams and vendors to high regulatory standards.

The role emphasizes quality systems, CAPA effectiveness, and reporting to senior management. 2 days weekly in Porto, with remote/hybrid flexibility to support global trials.

Qualificações

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

Responsabilidades

• Provide GCP quality oversight and guidance to trial teams, and represent quality on internal clinical committees.
• Lead or support audits of MoonLake and vendors, and manage CAPA resolution with owners and CRO leads.
• Support inspection readiness and manage regulatory inspections.
• Maintain and monitor the QMS to ensure compliance with regulatory requirements.
• Develop and monitor quality metrics and dashboards for senior management and teams.
• Report progress and issues to the Director, GCP and governance bodies.

Conhecimentos

GCP Quality Oversight

Audit & CAPA

Quality Risk Management

Regulatory Guidance

Vendor Oversight

Communication

Documentation

GCP Audits

Formação académica

Bachelor's degree in life science or healthcare field

Descrição da oferta de emprego

MoonLake Immunotherapeutics is seeking a Manager Quality (GCP) to ensure robust GCP compliance across clinical development programs. You will lead audits, manage quality risks, and support inspections readiness while guiding trial teams and vendors to high regulatory standards.

The role emphasizes quality systems, CAPA effectiveness, and reporting to senior management. 2 days weekly in Porto, with remote/hybrid flexibility to support global trials.