GCP Compliance Director (Program & Study)

Salary Range:

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Job Description Summary

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 were committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 90300.00 - 167700.00 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 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:

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 diverseteamsrepresentative of the patients and communities we serve.

Skills Desired