NEW: Senior Clinical Quality Assurance Manager

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

NEW: Senior Clinical Quality Assurance Manager

We are seeking an experienced Senior Clinical Quality Assurance Manager to lead Clinical Quality Assurance (CQA) activities supporting clinical research and drug development across multiple therapeutic areas and stages of product development.

This role will provide strategic and operational quality oversight, ensuring clinical research activities comply with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, study protocols and established quality standards.

Working collaboratively with clinical development, regulatory, quality and external research partners, you will lead audit programmes, provide quality guidance to study teams, support regulatory inspection readiness and drive continuous improvement across clinical quality systems. The position also offers the opportunity to lead, mentor and develop junior team members.

Travel: Up to 25%

The Role

Key responsibilities

Clinical quality assurance and audit management

• Lead the planning, coordination and execution of GCP audits, including clinical investigator sites, external vendors and internal processes.
• Develop and implement risk-based audit plans aligned with clinical development programmes and broader quality objectives.
• Oversee audit resources, including external audit consultants, and coordinate communications with relevant internal and external stakeholders.
• Support the selection of clinical sites and vendors for audit activities based on risk and programme requirements.
• Ensure audits are completed, documented, reported and closed out within established timelines.
• Maintain accurate audit documentation, schedules and tracking systems, and provide audit status updates and performance metrics to management.
• Communicate audit findings clearly and objectively, supporting appropriate escalation and effective resolution of identified issues.

Clinical study and programme support

• Act as the Clinical Quality Assurance lead for complex clinical development programmes, including studies requiring specialist quality oversight.
• Assess clinical investigator, study site and vendor compliance risks, escalating concerns and recommending appropriate actions where necessary.
• Advise study teams on quality issues, remediation activities and corrective and preventive action (CAPA) plans.
• Support regulatory inspection readiness at clinical investigator sites, including preparation activities, coordination and review of inspection findings and responses.
• Deliver GCP training and provide quality guidance to clinical study teams and relevant stakeholders.

Quality systems and continuous improvement

• Contribute to the development, maintenance and standardisation of quality procedures, processes and training materials.
• Identify opportunities to strengthen quality systems and improve the consistency and effectiveness of clinical development activities.
• Develop and evaluate quality metrics, including audit findings, deviations, CAPAs and other GCP-related quality indicators.
• Use quality data and emerging trends to identify compliance risks and recommend improvements.
• Collaborate with quality and clinical development colleagues to implement continuous improvement initiatives and promote a strong quality culture.

Leadership and cross-functional collaboration

• Provide day-to-day leadership, coaching and support to junior team members.
• Contribute to recruitment, onboarding, mentoring and professional development activities.
• Partner with quality leadership and cross-functional stakeholders to develop and implement effective compliance strategies.
• Support organisational regulatory inspections and other quality initiatives as required.
• Contribute to wider quality assurance projects where needed.

Requirements

About you

You will be an experienced clinical quality professional with a strong background in GCP compliance, clinical auditing and pharmaceutical or biotechnology drug development. You will combine detailed regulatory knowledge with sound judgement, effective communication and the ability to influence stakeholders at different levels.

Essential experience and qualifications

• Significant experience in Clinical Quality Assurance within a drug development environment.
• Extensive knowledge of applicable clinical trial regulations, ICH GCP guidelines and relevant regulatory requirements.
• Experience developing and implementing audit programmes and conducting audits of clinical investigator sites and clinical research vendors across Phase I–IV studies.
• Strong understanding of audit principles, techniques, documentation, reporting and follow-up.
• Experience assessing regulatory compliance risks, investigating findings and supporting the implementation of effective corrective and preventive actions.
• Demonstrated ability to interpret regulatory requirements and communicate their practical application to relevant stakeholders.
• Experience working collaboratively with internal teams, external service providers and clinical research partners.

Key skills and competencies

• Strong leadership, mentoring and team development skills.
• Excellent written and verbal communication, including the ability to present audit findings and complex regulatory requirements clearly.
• Strong analytical, problem-solving and critical-thinking abilities.
• Effective project management skills, with the ability to manage multiple priorities and deadlines while maintaining accuracy and attention to detail.
• A proactive approach to identifying compliance risks, resolving issues and driving continuous improvement.
• The ability to build productive working relationships and influence stakeholders across multidisciplinary teams.
• Strong organisational and documentation management skills, supported by good IT skills.
• International GCP experience and familiarity with regulatory requirements across multiple jurisdictions are desirable.

What the role offers

This is an opportunity to take a leading role in clinical quality assurance within a multidisciplinary drug development environment. You will contribute to the integrity and compliance of clinical research programmes, influence quality standards and processes, and support the development of colleagues while working across a diverse range of clinical studies and external partnerships.

G&L Scientific is committed to equal opportunities and creating an inclusive environment where everyone is treated fairly, with dignity and respect.

We welcome applications from all suitably qualified candidates, regardless of age, disability, gender identity, marital status, pregnancy or maternity, race, religion or belief, sex, sexual orientation, or any other characteristic protected by applicable law.

We are committed to fair and inclusive recruitment practices and encourage applications from people of all backgrounds.