GCP Compliance Director (Program & Study)

Overview

As GCP Compliance Director you will lead quality, compliance and operational excellence across global clinical portfolios. You’ll oversee a team of GCP Compliance Managers and drive inspection readiness, risk mitigation, and adherence to GCP and regulatory standards. You’ll partner with Development Units and cross-functional teams to strengthen compliance capabilities and portfolio quality, shaping a proactive culture of quality and continuous improvement. This role offers strategic impact on portfolio delivery and the evolution of a global compliance function.

Pay / Benefits

• flexible and hybrid working options
• minimum 14 weeks paid parental leave
• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs

Responsibilities

• Provide compliance oversight across Global Clinical Operations activities in assigned Development Units and portfolios
• Lead, coach and develop a high-performing team of GCP Compliance Managers
• Drive program and trial compliance with GCP and regulatory requirements
• Oversee Quality Delivery, including issues, deviations, and quality events
• Manage audit and inspection readiness, including CAPA development
• Oversee GCP compliance delivery pillars (audits, inspections, quality issues, self-assessments)
• Identify and communicate quality trends for timely action
• Partner with Development Unit leadership and cross-functional stakeholders to strengthen outcomes
• Contribute to advancing GCP Compliance frameworks, standards and operating models

Key requirements

• Advanced degree in Life Sciences or related field
• Significant experience in pharma/biotech/CRO with 10+ years in clinical research and drug development
• Proven track record in leading and mentoring teams within global, matrixed settings
• Extensive clinical operations experience and deep knowledge of trial execution and portfolio delivery
• Strong quality and compliance expertise including audits, inspections, investigations and CAPA
• Deep knowledge of Good Clinical Practice, international standards and global regulatory requirements
• Strategic oversight capabilities to translate quality insights into business decisions
• Experience influencing senior leaders and building partnerships across functions
• Strong strategic thinking, risk management, decision-making, and communication skills
• Commitment to a culture of trust, integrity, and continuous learning
• Desirable: experience building or strengthening quality and compliance frameworks

• Leadership and people management
• Collaboration and cross-functional influence
• Critical thinking and decision-making
• Good Clinical Practice (GCP)
• Regulatory compliance
• Audit and inspection management

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