At a Glance
- Tasks: Lead GCP compliance across clinical trials, ensuring quality and regulatory standards.
- Company: Join Novartis, a leader in innovative medicine with a commitment to diversity.
- Benefits: Competitive salary, performance bonuses, flexible working, and generous parental leave.
- Other info: Dynamic role with opportunities for growth and collaboration in a supportive environment.
- Why this job: Make a real impact on patient care while developing your leadership skills.
- Qualifications: Advanced degree in Life Sciences and significant experience in clinical research required.
The predicted salary is between 51000 - 155090 £ per year.
Location: Westworks, London, UK
Relocation Support: This role is based in London, UK. Novartis is unable to offer relocation support: please only apply if accessible. The preferred working arrangement is Hybrid, with an expectation of 12 days per month onsite at our Westworks, London office. Remote working can be discussed, subject to eligibility criteria being met of being resident more than 50 miles from our London offices.
Play a pivotal role in strengthening GCP compliance across one of Novartis' most operationally complex clinical research regions. As GCP Compliance Director (EMEA Hub), you will provide oversight and control of regulated Global Clinical Operations activities across a defined EMEA Hub and Country footprint, ensuring clinical trials are conducted in accordance with Good Clinical Practice requirements, regulatory expectations, and Novartis quality standards.
About The Role
You will provide oversight for key GCP Compliance core delivery pillars, including quality issue management, audits, inspections, and self-assessments, while partnering closely with clinical operations teams to strengthen inspection readiness, active risk management, and operational excellence. This highly visible leadership role offers the opportunity to influence compliance strategy, build trusted relationships across Global Clinical Operations and senior leadership, develop high-performing teams, and help ensure the generation of reliable scientific evidence that supports the development of innovative medicines for patients worldwide.
Key Responsibilities
- Accountable for the compliance oversight and control of regulated Global Clinical Operations activities across the assigned EMEA Hub and Country footprint, including country-level clinical trial conduct.
- Lead, coach, mentor, and develop a high-performing GCP Compliance team, fostering trust, capability growth, accountability, and a strong quality culture.
- Provide oversight and support to clinical site management teams, strengthening GCP compliance, risk management, and operational excellence across the assigned scope.
- Oversee Hub and Country quality issues, deviations, and compliance events, including investigations, root cause analysis, and Corrective and Preventive Action development.
- Oversee and coordinate Hub and Country audits and regulatory inspections from preparation and execution through Corrective and Preventive Action implementation and effectiveness verification.
- Monitor compliance risks, quality trends, and key performance indicators, ensuring timely escalation of significant concerns and proactive mitigation strategies.
- Partner with senior Global Clinical Operations, Quality Assurance, and Development leaders to influence compliance strategy, inspection readiness, and continuous improvement initiatives.
Essential Requirements
- Preference for an advanced degree in Life Sciences or a related discipline. Postgraduate qualifications in a relevant field would be beneficial.
- Significant experience within the pharmaceutical industry, combined with deep knowledge of the clinical research and clinical trial landscape, including clinical operations, site management, trial conduct, and the application of Good Clinical Practice requirements across the study lifecycle.
- Extensive experience leading Good Clinical Practice compliance, quality oversight, and regulated clinical operations activities across regional or global organizations, including oversight of country-level clinical trial conduct.
- Demonstrated expertise managing regulatory inspections, Good Clinical Practice audits, compliance investigations, root cause analyses, and Corrective and Preventive Action activities, with a proven ability to identify risks and drive sustainable compliance outcomes.
- Proven people leadership experience with a track record of coaching, mentoring, and developing high-performing teams, fostering trust, accountability, collaboration, and a strong culture of quality and compliance.
- Strong stakeholder engagement and influencing skills, with experience partnering with senior leaders in Global Clinical Operations, Quality Assurance, and cross-functional organizations to drive compliance, inspection readiness, operational excellence, and organizational change.
Desirable Requirements
- Openness to adopting and leveraging artificial intelligence, automation, and emerging digital technologies to enhance compliance oversight, risk management, inspection readiness, and operational effectiveness within clinical development environments.
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.
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?
GCP Compliance Director (EMEA Hub) in London employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer that fosters a culture of innovation and collaboration. Our commitment to employee growth is evident through our comprehensive benefits package, flexible working options, and a strong focus on diversity and inclusion, ensuring that every team member feels valued and empowered. Join us in our mission to reimagine medicine while enjoying a rewarding career in a dynamic environment that prioritises your professional and personal well-being.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Compliance Director (EMEA Hub) in London
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We think you need these skills to ace GCP Compliance Director (EMEA Hub) in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Novartis UK!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Novartis UK that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Novartis UK!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Novartis UK, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Novartis UK
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Novartis UK that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
