VACANCY
Director Quality Assurance
As Director Quality Assurance, you are responsible for independent quality oversight across the organization. You play a key role in ensuring compliance, driving continuous improvement, and embedding a strong, risk-based quality culture.
Reporting directly to the CEO, you act as a strategic advisor to senior leadership on quality performance, regulatory risk, and organizational effectiveness. You combine strong leadership with deep GxP expertise to ensure the organization remains inspection-ready and compliant at all times.
Key Responsibilities
Quality Oversight
- Advise Clinical Operations, project teams, and senior management on key quality risks and compliance matters
- Oversee and continuously improve the quality issue management process
Assess the severity, impact, and regulatory reportability of quality events - Review and approve CAPAs (Corrective and Preventive Actions)
- Support investigations, root cause analysis, and risk management activities
Audit Management
- Develop and execute the annual risk-based audit program
- Lead and/or oversee internal, vendor, and investigator site audits
- Ensure timely audit reporting and effective follow-up of findings
- Support and host client audits and regulatory inspections (e.g., EMA, FDA)
- Monitor CAPA implementation and effectiveness
Quality Management System (QMS)
- Ensure an effective, compliant, and fit-for-purpose QMS
- Maintain compliance with GxP, ICH-GCP, GDPR, and other applicable regulations
- Author and oversee QA-owned SOPs
- Drive process optimization and continuous improvement initiatives
Stakeholder Engagement & Communication
- Act as an independent QA partner to internal and external stakeholders
- Maintain strong relationships with sponsors, clients, and strategic partners
- Communicate audit outcomes and quality risks clearly and constructively
Leadership & Culture
- Foster a culture of quality, accountability, and continuous improvement
- Provide regular quality metrics and risk reports to senior leadership
- Lead inspection readiness across the organization
- Escalate significant quality or compliance risks to the CEO when required
Your Profile
- Bachelor’s or Master’s degree in Life Sciences or a related field
- Minimum 10 years of experience in clinical research, including at least 7 years in Quality Assurance
- Proven experience in developing and managing audit programs
- Strong knowledge of GCP and good understanding of other GxP areas
- Up-to-date knowledge of ICH-GCP, GDPR, and international regulatory requirements
- Strong leadership, analytical, and communication skills
- Ability to operate independently and confidently escalate risks
- Experience with Quality Management Systems and Computerized System Validation (CSV)
- Fluent in English (Dutch is a plus)
What We Offer
- A strategic leadership role with direct impact on the organization
- Close collaboration with executive leadership and international stakeholders
- Opportunity to shape and strengthen the quality culture
- Competitive salary and attractive benefits package
- Flexible and hybrid working environment
Interested?
Are you the quality leader we are looking for? Apply now or contact us for more information.
We would love to hear from you! Please send motivation and resume to info@cr2o.nl.