GCP Compliance Director (EMEA Hub)

Salary Range:

£83,510.00 - £155,090.00

 

Job Description Summary

#LI-Hybrid

Location: Westworks, London, UK

Relocation Support: This role is based in London, UK. Novartis is unable to offer relocation support: please only apply if accessible.

The preferred working arrangement is Hybrid, with an expectation of 12 days per month onsite at our Westworks, London office. Remote working for can be discussed, subject to eligibility criteria being met of being resident more than 50 miles from our London offices.

Play a pivotal role in strengthening GCP compliance across one of Novartis' most operationally complex clinical research regions. As GCP Compliance Director (EMEA Hub), you will provide oversight and control of regulated Global Clinical Operations activities across a defined EMEA Hub and Country footprint, ensuring clinical trials are conducted in accordance with Good Clinical Practice requirements, regulatory expectations, and Novartis quality standards.

 

Job Description

You will provide oversight for key GCP Compliance core delivery pillars, including quality issue management, audits, inspections, and self-assessments, while partnering closely with clinical operations teams to strengthen inspection readiness, active risk management, and operational excellence. This highly visible leadership role offers the opportunity to influence compliance strategy, build trusted relationships across Global Clinical Operations and senior leadership, develop high-performing teams, and help ensure the generation of reliable scientific evidence that supports the development of innovative medicines for patients worldwide.

Key Responsibilities

• Accountable for the compliance oversight and control of regulated Global Clinical Operations activities across the assigned EMEA Hub and Country footprint, including country-level clinical trial conduct.

• Lead, coach, mentor, and develop a high-performing GCP Compliance team, fostering trust, capability growth, accountability, and a strong quality culture.

• Provide oversight and support to clinical site management teams, strengthening GCP compliance, risk management, and operational excellence across the assigned scope.

• Oversee Hub and Country quality issues, deviations, and compliance events, including investigations, root cause analysis, and Corrective and Preventive Action development.

• Oversee and coordinate Hub and Country audits and regulatory inspections from preparation and execution through Corrective and Preventive Action implementation and effectiveness verification.

• Monitor compliance risks, quality trends, and key performance indicators, ensuring timely escalation of significant concerns and proactive mitigation strategies.

• Partner with senior Global Clinical Operations, Quality Assurance, and Development leaders to influence compliance strategy, inspection readiness, and continuous improvement initiatives.

Essential Requirements

• Preference for an advanced degree in Life Sciences or a related discipline. Postgraduate qualifications in a relevant field would be beneficial.

• Significant experience within the pharmaceutical industry, combined with deep knowledge of the clinical research and clinical trial landscape, including clinical operations, site management, trial conduct, and the application of Good Clinical Practice requirements across the study lifecycle.

• Extensive experience leading Good Clinical Practice compliance, quality oversight, and regulated clinical operations activities across regional or global organizations, including oversight of country-level clinical trial conduct.

• Demonstrated expertise managing regulatory inspections, Good Clinical Practice audits, compliance investigations, root cause analyses, and Corrective and Preventive Action activities, with a proven ability to identify risks and drive sustainable compliance outcomes.

• Proven people leadership experience with a track record of coaching, mentoring, and developing high-performing teams, fostering trust, accountability, collaboration, and a strong culture of quality and compliance.

• Strong stakeholder engagement and influencing skills, with experience partnering with senior leaders in Global Clinical Operations, Quality Assurance, and cross-functional organizations to drive compliance, inspection readiness, operational excellence, and organizational change.

Desirable Requirements

• Openness to adopting and leveraging artificial intelligence, automation, and emerging digital technologies to enhance compliance oversight, risk management, inspection readiness, and operational effectiveness within clinical development environments.

 

Skills Desired

Audit Processes, Biopharmaceutical Industry, Budget Management, Clinical Research Trials, Clinical Studies, Clinical Trials, Clinical Trials Operations, Good Clinical Practice (GCP), Health Sciences, Leadership, People Management, Pharmaceutical Industry, Regulatory Compliance, Site Inspections, Stakeholder Engagement, Team Management, Training and Development