Senior Clinical QA Leader: GCP Audits & Compliance

G&L Scientific; Netherlands; On-site; EUR 120,000 - 180,000; Full time

Job summary

G&L Scientific in the Netherlands is seeking a Senior Clinical Quality Assurance Manager to lead clinical quality oversight across multiple development programmes. You will drive GCP audit programmes, advise study teams and ensure regulatory readiness with external partners.

The role offers leadership of junior staff, development of quality systems and performance metrics, and collaboration with clinical development, regulatory and quality teams to sustain high compliance standards across Phase

Qualifications

• Significant experience in Clinical Quality Assurance within drug development.
• Extensive knowledge of ICH GCP guidelines and regulatory requirements.
• Experience developing and implementing audit programmes across Phase I–IV studies.
• Ability to interpret regulatory requirements and communicate practical applications to stakeholders.
• Experience collaborating with internal teams, external vendors and clinical research partners.

Responsibilities

• Lead planning, coordination and execution of GCP audits.
• Develop risk-based audit plans aligned with development programmes and quality objectives.
• Oversee audit resources and coordinate communications with stakeholders.
• Support regulatory inspection readiness at clinical sites and vendors.
• Deliver GCP training and provide quality guidance to study teams.
• Contribute to quality systems and continuous improvement initiatives.

Skills

Leadership

Audit management

GCP compliance

Regulatory knowledge

Communication

Cross-functional collaboration

Mentoring

Job description

G&L Scientific in the Netherlands is seeking a Senior Clinical Quality Assurance Manager to lead clinical quality oversight across multiple development programmes. You will drive GCP audit programmes, advise study teams and ensure regulatory readiness with external partners.

The role offers leadership of junior staff, development of quality systems and performance metrics, and collaboration with clinical development, regulatory and quality teams to sustain high compliance standards across Phase