17 oct
|
Novartis
|
Sabadell
Salary Range: €85,100.00 - €158,100.00 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. Hybrid Working Novartis operates a Hybrid working policy with an expectation of 12 days per month onsite. 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 integral 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 #J-18808-Ljbffr
📌 GCP Compliance Director (Program & Study) (Sabadell)
🏢 Novartis
📍 Sabadell