NEW: Senior Director, Clinical Quality Assurance

G&L Scientific; Netherlands; On-site; EUR 180,000 - 260,000; Full time

Job summary

G&L Scientific is seeking a Senior Director of Clinical Quality Assurance to lead strategic quality across a diverse development portfolio and ensure GCP compliance globally.

You will partner with Clinical Development, Regulatory Affairs and Pharmacovigilance to shape QA strategy, oversee audits, inspections, CAPA, and drive continuous improvement while managing senior stakeholders.

Qualifications

• Extensive experience leading Clinical QA programs and strategy.
• Deep knowledge of ICH-GCP and global regulatory expectations.
• Strategic leadership with executive communication skills.
• Experience with regulatory inspections and CAPA oversight.
• Proven people leadership and talent development capabilities.
• Strong cross-functional collaboration with regulators and partners.

Responsibilities

• Develop and implement multi-year Clinical QA strategies and roadmaps.
• Lead regulatory inspections readiness and remediation activities.
• Oversee global audit and CAPA programmes for investigators, CROs, and labs.
• Provide strategic quality input into regulatory submissions and interactions.
• Establish meaningful quality metrics and governance structures.
• Collaborate with senior leaders to embed quality in strategic decisions.
• Mentor and develop Clinical QA leaders and teams.

Skills

Clinical QA leadership

GCP compliance

Regulatory inspections

Quality systems

Risk management

Stakeholder management

People leadership

Job description

NEW: Senior Director, Clinical Quality Assurance

We are seeking an accomplished Senior Director of Clinical Quality Assurance (Clinical QA) to lead the strategic direction and operational delivery of clinical quality assurance across a diverse clinical development portfolio.

This senior leadership position will be responsible for establishing and implementing clinical quality strategies, strengthening Good Clinical Practice (GCP) compliance, and ensuring effective quality oversight throughout clinical development and, where applicable, commercial activities.

Working closely with senior leaders across Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics and other functions, you will provide strategic quality guidance on complex regulatory and compliance matters. You will lead clinical audit and inspection readiness programmes, oversee clinical quality management systems, and drive continuous improvement in response to evolving regulatory expectations and business priorities.

The successful candidate will combine extensive technical expertise in clinical quality and global GCP regulations with strong executive leadership, strategic planning and organisational development capabilities.

Travel: Up to 25%

The Role

Clinical quality strategy and leadership

• Develop and implement multi-year Clinical QA strategies and operational plans aligned with organisational objectives and clinical development priorities.
• Define the vision, strategic priorities, operating model, capabilities and long-term roadmap for Clinical QA.
• Provide senior-level quality leadership across the clinical development portfolio, promoting a proactive and consistent culture of quality, compliance and patient safety.
• Act as a trusted strategic advisor to senior stakeholders on complex compliance issues, emerging regulatory risks and the interpretation of global GCP requirements.
• Anticipate changes in the regulatory and industry landscape, assessing their potential impact on clinical development activities, quality systems and organisational capabilities.
• Establish clear performance objectives, governance structures and measures of success to evaluate the effectiveness of Clinical QA activities.

Regulatory inspections and audit oversight

• Lead the organisation's approach to regulatory inspection readiness and inspection management, including preparation planning, mock inspections, pre-approval inspections and responses to regulatory authorities.
• Provide senior quality oversight of inspection-related findings, commitments and remediation activities.
• Establish and oversee risk-based global audit and compliance programmes covering clinical investigator sites, Contract Research Organisations (CROs), clinical laboratories, vendors and other external research partners.
• Ensure significant quality and compliance risks are identified, assessed, escalated and addressed through effective corrective and preventive action (CAPA) processes.
• Oversee internal clinical quality audits to evaluate compliance with applicable regulations, GCP principles, procedures and clinical research requirements.
• Provide strategic quality input into regulatory submissions and interactions, including investigational applications, clinical trial applications and marketing applications.
• Build effective relationships with regulatory authorities, clinical research partners and other external stakeholders.

Clinical quality systems and risk management

• Direct the development, governance, implementation and continuous improvement of the Clinical Quality Management System (QMS).
• Ensure quality systems and processes remain effective, scalable, risk-based and aligned with evolving global regulatory expectations.
• Establish meaningful quality metrics, performance indicators and trend analysis to identify systemic issues, emerging risks and opportunities for improvement.
• Present quality insights, risk assessments and recommendations to senior leadership to support informed decision-making.
• Oversee clinical quality activities relating to pharmacovigilance, Phase IV studies, investigator-initiated trials and other clinical research activities within the remit of Clinical QA.
• Collaborate across functions to resolve complex quality and compliance challenges, balancing regulatory obligations, patient safety and organisational objectives.
• Support the development and implementation of robust quality procedures, governance frameworks and risk-based compliance strategies.
• Partner with senior leaders across clinical development, regulatory affairs, clinical operations, drug safety and other relevant functions to embed quality considerations into strategic and operational decisions.
• Influence cross-functional decisions on significant compliance risks and complex regulatory matters.
• Communicate quality strategy, performance, emerging risks and remediation priorities clearly to executive stakeholders.
• Represent Clinical QA in interactions with regulatory authorities, external partners and relevant industry forums, as appropriate.
• Promote accountability, ethical conduct, continuous improvement and consistent quality standards across the organisation.

People leadership and organisational development

• Lead, develop and mentor Clinical QA leaders and professional teams.
• Build and maintain high-performing teams with the expertise and capabilities required to support current and future clinical development needs.
• Establish workforce plans, resource priorities and organisational development strategies.
• Drive talent development, coaching, succession planning and performance management.
• Manage departmental budgets, resource allocation and external partnerships to support effective delivery of strategic and operational objectives.

Requirements

About you

You are a strategic and commercially aware quality leader with extensive experience in pharmaceutical, biotechnology or a related regulated life sciences environment. You have a proven track record of leading clinical quality assurance functions, navigating complex regulatory requirements and building effective relationships with senior stakeholders.

You are comfortable operating at executive level while maintaining the technical depth required to assess complex GCP compliance issues, guide regulatory inspection activities and strengthen quality systems across a clinical development portfolio.

Essential experience and qualifications

• Extensive industry experience in clinical quality assurance, GCP compliance and clinical development within pharmaceutical, biotechnology or another relevant regulated life sciences environment.
• Significant leadership experience in Clinical QA, including responsibility for strategy, quality systems, audit programmes, regulatory inspections and compliance oversight.
• Expert knowledge of applicable clinical trial regulations, ICH GCP guidelines and international regulatory requirements, including relevant US FDA and European regulatory expectations.
• Extensive experience developing and overseeing risk-based audit programmes covering investigator sites, CROs, clinical laboratories, vendors and other clinical research partners across Phase I–IV studies.
• Strong experience leading or providing senior quality oversight for regulatory inspection preparation, inspection management, responses and remediation.
• Demonstrated success in developing, implementing and continuously improving clinical quality systems, governance frameworks, processes and procedures.
• Extensive knowledge of quality risk management, audit methodology, CAPA processes and the identification of systemic compliance issues.
• Experience assessing complex regulatory and quality risks and translating findings into effective strategic and operational responses.
• Significant people leadership experience, including leading managers or senior professionals, developing talent and building organisational capability.
• Proven ability to work effectively with senior cross-functional leaders, external partners and regulatory authorities.
• Experience managing competing priorities, complex workstreams, budgets and resources in a dynamic clinical development environment.

Key leadership competencies

• Strategic thinking: Ability to translate long-term organisational objectives into clear quality strategies, operational plans and measurable outcomes.
• Executive communication: Exceptional communication, influencing and stakeholder management skills, including the ability to present complex regulatory matters to senior leadership.
• Risk-based decision-making: Sound judgement and the ability to assess complex, ambiguous or emerging risks while balancing compliance, patient safety and business priorities.
• Organisational leadership: Proven ability to build high-performing teams, develop future leaders and establish clear accountability.
• Cross-functional influence: Ability to align stakeholders with different priorities and drive effective solutions across organisational boundaries.
• Continuous improvement: A proactive approach to strengthening quality culture, systems, governance and operational effectiveness.
• Adaptability: Ability to respond effectively to changing regulatory expectations, evolving development portfolios and complex business challenges.
• Working knowledge of Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) requirements across the product lifecycle.
• Experience supporting clinical quality oversight across both development and commercial-stage products.
• Experience engaging with international regulatory authorities and contributing to broader industry quality initiatives.

This is an opportunity to shape clinical quality strategy at a senior leadership level, influence quality standards across a clinical development portfolio and contribute directly to regulatory compliance, patient safety and the successful delivery of clinical research.

You will have the opportunity to build organisational capabilities, develop high-performing teams and partner with senior stakeholders to embed quality into strategic decision-making and clinical development operations.

Interested in leading clinical quality at a strategic level? If you bring extensive GCP expertise, a strong record of quality leadership and the ability to drive meaningful organisational improvement, we welcome your application.

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.