{bc}
Apply
workday

GCP Compliance Director (Program & Study)

Novartis
London, GBR
Full-time
Director · 10+ years experience
Onsite
£83,510.00 - £155,090.00
Discovered 2 weeks ago
GCP

Full Job Posting

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: 83,510.00 - 155,090.00 GBP 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.
  • 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

Qualifications

  • 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
  • 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: 83,510.00 - 155,090.00 GBP 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.
  • 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.
  • 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.

Preferred Qualifications

  • Desired
  • In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
  • Skills Desired

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at Novartis

Marketing Associate - Maseeraty Graduate Program, UAE

, UAE

Discovered TodayContract

Research Scientist II, Biochemistry

, USA

Discovered TodayFull-time

Global Process Manager

London, GBR

Discovered TodayFull-time

WORKFORCE STRATEGY HEAD, ENTERPRISE DATA SCIENCE & ARTIFICIAL INTELLIGENCE (DSAI)

London, GBR

Discovered TodayFull-time

Direct Materials Life Cycle Manager

Hyderabad, IND

Discovered TodayFull-time

Senior Principal Clinical Data Scientist

Hyderabad, IND

Discovered TodayFull-time

Neuroscience Territory Account Specialist – Worcester / Bridgeport

, USA

Discovered TodayFull-time

Marketing Associate - Maseeraty Graduate Program, UAE

, UAE

Discovered TodayFull-time