Senior GCP Quality Lead — Hybrid/Remote

Moonlaketx; Portugal; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Learning Environment

Impactful Work

Flexibility and Balance

Career Growth

Resumo da oferta

MoonLake seeks a Manager Quality (GCP) to ensure robust GCP compliance across clinical development programmes. You will lead audits, manage quality risks, and support inspections readiness while providing operational quality support to clinical teams and vendors.

Responsibilities include governance of quality issues, CAPA, and collaboration with CRO leads. This role requires strong GCP knowledge and excellent communication in a hybrid Porto-based environment.

Qualificações

• Bachelor's degree in life science or healthcare preferred.
• Experience managing quality issues and CAPAs in biotechnology/biopharma.
• Proven track record monitoring GCP compliance in biotech/biopharma.
• Experience conducting GCP clinical audits as lead or support auditor.
• Experience with quality oversight of clinical trials from protocol development to reporting.

Responsabilidades

• Provide GCP Quality Oversight and clinical trial support across MoonLake and vendors.
• Offer quality guidance to assigned clinical trial teams as sponsor Study GCP Quality Lead.
• Attend internal clinical meetings and provide Quality representation on trials.
• Collaborate within GCP team to oversee all GCP activities in MoonLake and subcontractors.
• Oversee quality risk management processes to ensure inspection readiness.
• Lead CAPA and CAPA-effectiveness checks for assigned programmes.
• Conduct internal and external GCP/GCLP audits; support vendor qualifications and QA assessments.
• Support GCP inspection readiness activities and regulatory inspections.
• Maintain and monitor the QMS to meet regulatory requirements for GCP compliance.
• Track quality metrics and dashboards for senior management and study teams.
• Report progress and issues to the Director, GCP.

Conhecimentos

GCP knowledge

Audit processes

CAPA management

Quality risk management

Regulatory compliance

Clinical trial oversight

Stakeholder communication

CRO collaboration

Quality documentation

GxP systems

Formação académica

Bachelor's degree in life science or healthcare

Descrição da oferta de emprego

MoonLake seeks a Manager Quality (GCP) to ensure robust GCP compliance across clinical development programmes. You will lead audits, manage quality risks, and support inspections readiness while providing operational quality support to clinical teams and vendors.

Responsibilities include governance of quality issues, CAPA, and collaboration with CRO leads. This role requires strong GCP knowledge and excellent communication in a hybrid Porto-based environment.