At a Glance
- Tasks: Lead GCP compliance and oversee clinical operations across the EMEA region.
- Company: Join Novartis, a diverse and inclusive employer committed to innovation.
- Benefits: Competitive salary, flexible working options, and comprehensive benefits package.
- Other info: Opportunity for career growth in a dynamic and supportive environment.
- Why this job: Make a real impact in clinical research and help develop innovative medicines.
- Qualifications: Advanced degree in Life Sciences and significant experience in clinical research.
The predicted salary is between 51000 - 155090 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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) employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid work model allows for flexibility while providing ample opportunities for professional growth and development in the pharmaceutical industry. With a commitment to enhancing customer experiences for healthcare professionals and patients alike, joining our team means contributing to meaningful work that makes a difference in people's lives.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Compliance Director (EMEA Hub)
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Novartis looking for candidates who are engaged and informed.
We think you need these skills to ace GCP Compliance Director (EMEA Hub)
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Novartis. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Novartis
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Novartis’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
