GCP Compliance Director (Program & Study)
hace 1 día
Sabadell
€85,100.00 - €158,100.00 #LI-Hybrid Barcelona, Spain 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. • 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., • 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., • 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. At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen. 85,1 #J-18808-Ljbffr