GCP Compliance Director (Program & Study)

DTX Pharma, a Novartis Company; Barcelona; Hybrid; EUR 85,000 - 158,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Parental leave

Job summary

Novartis seeks a GCP Compliance Director (Program & Study) in Barcelona to lead a team and oversee compliance across global clinical portfolios. The role interfaces with Development Units, Quality, and Clinical Operations to ensure GCP standards and regulatory adherence.

The position emphasizes strategic oversight, risk mitigation, and building a proactive quality culture within a hybrid work model.

Qualifications

• Advanced degree in Life Sciences or related field; postgraduate qualifications beneficial.
• Significant pharma/biotech or CRO experience, incl. 10+ years in clinical research and drug development.
• Proven track record of leading and mentoring teams in global/matrixed organizations.
• Deep knowledge of GCP, clinical operations, and regulatory requirements.

Responsibilities

• Provide compliance oversight across Global Clinical Operations and portfolios.
• Lead and develop a high-performing team of GCP Compliance Managers.
• Drive program and trial compliance with GCP and regulatory requirements.
• Oversee audit/inspection readiness and CAPA development.
• Communicate trends and risks to Development Unit leadership and stakeholders.

Skills

Leadership

Strategic thinking

Risk management

Communication

Stakeholder influence

Education

Advanced degree in Life Sciences

Job description

Salary Range:
€85,100.00 - €158,100.00

Band
Level 6

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. 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.

Job Description

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 diverseteams’representative of the patients and communities we serve.

Skills Desired

Budget Management, Clinical Operations, Clinical Research, Clinical Research Operations, Clinical Research Trials, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Coaching, Compliance Awareness, Compliance Governance, Compliance Management, FDA Compliance, Good Clinical Practice (GCP), People Management, Regulatory Compliance, Risk Management, Risk Monitoring