Senior Director, Quality & Compliance – Europe

• Partner with the EVP, Global Quality to develop and execute the global quality and compliance strategy
• Provide leadership for quality management activities across all clinical research services
• Serve as a senior member of the Quality Leadership Team and contribute to enterprise quality governance initiatives
• Lead quality transformation and quality maturity initiatives
• Act as a senior quality representative for clients, sponsors, and strategic partners
• Lead and grow a team of Quality leads providing customer-facing support and internal operational partnership
• Support business development, proposals, bid defences, due diligence activities, and client governance meetings
• Present quality metrics, compliance trends, and quality improvement strategies to clients and executive stakeholders
• Provide strategic oversight of Quality Management System processes and governance
• Support the global governance framework for quality issue management and CAPA effectiveness
• Chair or oversee quality review forums covering significant quality events, root cause investigations, and remediation activities
• Provide executive oversight and strategic support for regulatory inspections, sponsor audits, and client assessments
• Support inspection preparation, response strategy, observation management, CAPA development, and regulatory commitments
• Monitor emerging regulatory requirements and industry expectations affecting clinical research organisations
• Support executive quality reviews and governance committees through data-driven insights and recommendations
• Assess quality and compliance risks and support risk mitigation strategies
• Provide expert consultation to senior leadership on quality, compliance, inspection readiness, and regulatory risk
• Contribute to enterprise risk management activities and quality-related strategic initiatives

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Quality, Regulatory Affairs, or related scientific discipline required
• Advanced knowledge of ICH-GCP, FDA regulations, EMA guidance, MHRA requirements, PMDA expectations, Vendor Governance applicable GxP regulations, Risk Management principles, Computerised Systems and 21 CFR Part 11, Quality Management Systems, and inspection readiness frameworks
• Strong understanding of the clinical development lifecycle and CRO operations
• Understanding of AI as applies to clinical research applications
• Strategic and enterprise mindset
• Strong customer focus and relationship management skills
• Exceptional communication and executive presence
• Ability to influence at all organisational levels
• High integrity, accountability, and commitment to quality excellence
• Minimum 10-15 years of progressive experience in Quality Assurance, Quality Management, Regulatory Compliance, or Clinical Research
• Minimum 7 years of leadership experience managing global teams
• Significant experience within CRO, pharmaceutical, biotechnology, or clinical research environments

• Equal employment opportunities
• Diverse and inclusive work environment
• Supportive and collaborative teams
• Professional growth and opportunity to succeed