GCP Compliance Director

Salary Range: €85,100.00
- €158,100.00 La siguiente información ofrece un resumen de las habilidades, cualidades y cualificaciones necesarias para este puesto.

Job Description
Summary #LI-Hybrid Location Barcelona, Spain Relocation Support: This role is based in Barcelona. Novartis is unable to offer relocation support: please only apply if accessible. Novartis operates a Hybrid working policy with an expectation of 12 days per month onsite. Quality, compliance, and operational excellence are critical to how Novartis delivers innovative medicines to patients worldwide.

Key Responsibilities
* Provide compliance oversight and control of regulated Global Clinical Operations activities across assigned Development Units and clinical trial portfolios.
* Lead, coach, mentor, and develop a high-performing team of GCP Compliance Managers, fostering engagement, growth, and accountability.
* Drive compliance oversight of programs and trials within assigned Development Units, ensuring alignment with Good Clinical Practice, regulatory requirements, and internal standards.
* Oversee Clinical Trial Team Good Clinical Practice Compliance support activities, strengthening operational excellence and quality delivery across the portfolio.
* Ensure effective management of quality issues, deviations, and quality events within assigned scope, including appropriate escalation and risk mitigation.
* Lead audit and inspection readiness activities, including preparation, execution, response management and corrective and preventive action development.
* Oversee assigned Good Clinical Practice Compliance delivery pillars, including audits, inspections, quality issues, and self-assessment activities across the Global Clinical Operations portfolio.
* Identify, assess, analyse, and communicate quality and compliance trends, ensuring timely action and informed decision-making.
* Partner with Development Unit leadership, Clinical Trial Teams, Quality, and cross-functional stakeholders to strengthen compliance capabilities and portfolio quality outcomes.
* Contribute to the continued advancement of Good Clinical Practice Compliance frameworks, standards, and operating models while promoting a proactive culture of quality, integrity, and continuous improvement. Essential Requirements
* Advanced degree in Life Sciences or a related scientific discipline. Postgraduate qualifications in relevant fields would be beneficial.
* Significant pharmaceutical, biotechnology, or Contract Research Organization experience, including at least 10 years within clinical research and drug development.
* Proven track record of leading, developing, and mentoring high-performing teams within complex global and matrixed organizations.
* Extensive clinical operations experience with deep knowledge of clinical trial execution, portfolio delivery, and the broader clinical research landscape.
* Strong quality and compliance expertise, including experience supporting or leading audits, inspections, investigations, quality events, and corrective and preventive action activities.
* In-depth knowledge of Good Clinical Practice, international clinical research standards, and global regulatory requirements.
* Demonstrated ability to provide strategic oversight of complex clinical portfolios while translating quality and compliance insights into business decisions.
* Experience influencing senior leaders and building effective partnerships across Development Units, Quality, Clinical Operations, and cross-functional stakeholder groups.
* Strong strategic thinking, critical thinking, risk management, and decision-making capabilities, with the ability to navigate complexity and ambiguity.
* Outstanding communication, collaboration, and leadership skills, combined with curiosity, integrity, self-awareness, humility, and a commitment to fostering a culture of trust and continuous learning. Desirable Requirements
* Experience in Quality Assurance, inspection management, or Good Clinical Practice compliance leadership supporting global clinical development programs.
* Demonstrated experience building, evolving, or strengthening quality, compliance, or operational excellence frameworks within a complex global organization. Benefits & Rewards At Novartis, we're committed to reimagining medicine together
- and rewarding the people who make it happen. Expected Annual Base Salary Range for role: 85,1 ,100.00 EUR Annual The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirem