GCP Compliance Director (Program & Study)

Novartis; Barcelona; Hybrid; EUR 85,000 - 158,000; Full time

Benefits offered by this job

Hybrid work options

14 weeks parental leave

Insurance & retirement plans

Job summary

Novartis in Barcelona seeks a GCP Compliance Director (Program & Study) to lead global clinical quality and regulatory compliance efforts. You will manage a team of GCP Compliance Managers, drive inspection readiness, and ensure alignment with GCP, regulatory requirements, and internal standards.

You will influence portfolio delivery, foster a culture of trust and continuous improvement, and collaborate with Development Units, Quality, and cross-functional teams.

Qualifications

• Advanced degree in Life Sciences or related field.
• Significant pharma/biotech or CRO experience in clinical research.
• Proven record of leading global, matrixed teams.
• Extensive knowledge of GCP, international standards and regulations.
• Ability to translate quality insights into business decisions.
• Experience influencing senior leaders and cross-functional partners.

Responsibilities

• Provide compliance oversight across Global Clinical Operations and development portfolios.
• Lead and develop a team of GCP Compliance Managers.
• Drive program and trial compliance with GCP and regulatory requirements.
• Oversee audits, inspections, quality events, and CAPA activities.
• Ensure proactive risk assessment and escalation of quality issues.
• Lead inspection readiness activities and corrective action plans.
• Communicate trends and insights to Develop Unit leadership and stakeholders.
• Support evolution of GCP compliance frameworks and operating models.

Skills

Leadership

GCP Compliance

Audit & Inspection

Regulatory Knowledge

Strategic Thinking

Education

Advanced life sciences degree

Job description

Summary

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.

As GCP Compliance Director (Program & Study), you will play a pivotal leadership role at the intersection of clinical development, quality, and regulatory compliance, providing strategic oversight across complex global clinical portfolios. Leading a team of experienced GCP Compliance Managers, you will help drive inspection readiness, strengthen quality oversight, mitigate risk, and ensure the consistent application of Good Clinical Practice and regulatory requirements across assigned Development Units. This is an opportunity to influence both portfolio delivery and the evolution of a growing global compliance function while fostering a culture grounded in collaboration, trust, integrity, curiosity, and continuous improvement.

About The Role

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: 85,100.00 - 158,100.00 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, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)