GCP Compliance Director (Program & Study)

Novartis; Sabadell; Ibrido; EUR 85.000 - 158.000; Tempo pieno

Descrizione del lavoro

Novartis in Barcelona is seeking a senior GCP Compliance leader to oversee Global Clinical Operations and drive QA excellence in a hybrid work setup. You will mentor a team across trials, ensure regulatory alignment, and partner with cross-functional leaders to elevate portfolio quality.

Ideal candidates hold an advanced Life Sciences degree, 10+ years in clinical research, and a proven track record in audits, inspections, and CAPA leadership.

Competenze

• Advanced degree in Life Sciences or related discipline.
• 10+ years in clinical research/pharma.
• Proven leadership in global matrix organizations.
• GCP, regulatory standards, and QA knowledge.

Mansioni

• Provide compliance oversight 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.
• Drive compliance oversight of programs and trials ensuring GCP and regulatory alignment.
• Oversee QA delivery, including audits, inspections, quality issues, and CAPA activities.
• Lead audit/inspection readiness, including response management and corrective actions.
• Identify quality trends and communicate risks to leadership.
• Collaborate with DU leadership, QA, and cross-functional stakeholders to improve portfolio quality.

Conoscenze

Leadership

GCP knowledge

Regulatory knowledge

Audits & inspections

Strategic thinking

Cross-functional collaboration

Formazione

Advanced degree in Life Sciences

Descrizione del lavoro

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 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