At a Glance
- Tasks: Lead compliance oversight for global clinical operations and mentor a high-performing team.
- Company: Join Novartis, a leader in innovative medicines with a commitment to quality and compliance.
- Benefits: Competitive salary, flexible working options, and comprehensive benefits including parental leave.
- Other info: Diverse and inclusive environment with opportunities for personal and professional growth.
- Why this job: Make a real impact on global clinical trials while fostering a culture of integrity and collaboration.
- Qualifications: Advanced degree in Life Sciences and significant experience in clinical research and compliance.
The predicted salary is between 51000 - 155090 £ per year.
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.
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.
- 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.
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.
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.
Compliance Monitoring Manager - Hybrid/Flexible Working in London 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 Compliance Monitoring Manager - Hybrid/Flexible Working in London
✨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 Compliance Monitoring Manager - Hybrid/Flexible Working in London
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!
