GCP Quality Compliance Lead

Position Summary

This role provides global oversight and governance for clinical quality systems, ensuring that trial delivery operations meet all regulatory expectations and internal quality standards. The individual will drive proactive quality risk management, support inspection readiness, and strengthen organizational compliance through partnership and continuous improvement initiatives.

Primary Responsibilities

• Oversee quality processes supporting clinical development activities, ensuring systems remain compliant and aligned with international GCP requirements.
• Implement and maintain effective control measures to ensure robust, audit-ready operations across global clinical programs.
• Collaborate with functional leaders to identify systemic gaps or risks, investigate issues, and develop effective CAPAs and preventive strategies.
• Serve as a trusted advisor to senior leadership on GCP compliance strategy, quality governance, and operational improvement initiatives.

Key Accountabilities

• Lead global inspection readiness and response programs, including strategy development, coordination with internal and external stakeholders, and post-inspection remediation.
• Monitor evolving regulatory trends and contribute to strategic risk mitigation and process optimization plans.
• Act as the primary contact during regulatory inspections, guiding SMEs and ensuring consistent communication of findings and mitigations.
• Manage inspection responses from preparation through final closure, ensuring thorough root-cause analysis, timely submission, and measurable CAPAs.
• Track CAPA execution and effectiveness, escalating risks as needed and supporting sustainable compliance solutions.
• Serve as the GCP quality expert for deviation investigations, CAPA management, and change control activities, as well as supporting other regulated domains (e.g., GMP, GVP).
• Lead complex quality investigations impacting clinical systems and drive cross-functional corrective actions.
• Capture and disseminate inspection learnings to reinforce organizational knowledge and improve future readiness.
• Champion cross-departmental continuous improvement projects to strengthen trial quality management frameworks.
• Review and approve controlled documents governing clinical quality systems, ensuring they meet evolving regulatory and organizational standards.
• Analyze compliance data and metrics to identify trends, emerging risks, and opportunities for improvement.
• Provide regular quality updates to leadership and contribute to governance councils and quality review boards.

Qualifications

• Bachelor’s degree in a scientific, medical, or allied health discipline (advanced degree preferred).
• Minimum of 7 years in the pharmaceutical or biotech sector, with a focus on clinical operations, data management, or biostatistics, including at least 3 years in a GCP quality/compliance capacity.
• Strong command of GCP, GVP, and international regulatory frameworks (FDA, EMA, MHRA, PMDA, ICH).
• Proven track record in developing audit or inspection readiness programs and leading global regulatory inspections.
• Demonstrated success in managing enterprise-wide compliance initiatives and cross-functional projects.
• Ability to analyze complex quality data, identify trends, and communicate findings to senior leadership.
• Excellent communication and stakeholder engagement skills; fluency in English required, additional languages desirable.