[Hiring] Senior Director, Quality & Compliance @Worldwide Clinical Trials

Role Description

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, ensuring alignment with corporate objectives and regulatory expectations.
• Serve as a senior member of the Quality Leadership Team and contribute to enterprise quality governance initiatives.
• Lead quality transformation and quality maturity initiatives that enhance operational effectiveness, inspection readiness, and client confidence.
• Act as a senior quality representative for clients, sponsors, and strategic partners.
• Lead and grow a team of Quality leads, assigned therapeutically to provide customer-facing support, leadership, and internal operational team partnership.
• Support business development, proposals, bid defenses, due diligence activities, and client governance meetings by providing quality and compliance expertise & oversight.
• Present quality metrics, compliance trends, and quality improvement strategies to clients and executive stakeholders.
• Provide strategic oversight of Quality Management System (QMS) processes and governance.
• Support the leadership of the global governance framework for quality issue management and CAPA effectiveness.
• Chair or oversee quality review forums to assess 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.
• Maintain awareness of emerging regulatory requirements and industry expectations affecting clinical research organizations.
• Support executive quality reviews and governance committees through data-driven insights and recommendations.
• Assess quality and compliance risks across operational functions and support effective 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.

Qualifications

• 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.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Quality, Regulatory Affairs, or related scientific discipline required.
• Advanced degree (MSc, PharmD, PhD, MBA) preferred.
• 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 (can be outside of the QA organisation).

Benefits

• We love knowing that someone is going to have a better life because of the work we do.