At a Glance
- Tasks: Lead quality assurance for clinical trials, ensuring compliance and patient safety.
- Company: Join Novartis, a leader in healthcare innovation with a global impact.
- Benefits: Enjoy competitive salary, professional growth opportunities, and a hybrid work environment.
- Other info: Dynamic role with opportunities for continuous improvement and career advancement.
- Why this job: Make a real difference in clinical development while working with top professionals.
- Qualifications: Bachelor's degree in life sciences; experience in clinical QA and GCP required.
The predicted salary is between 70000 - 90000 € per year.
The Associate Director, Clinical Quality Assurance (QA) will provide Quality oversight for the end‑to‑end clinical process for the clinical trials under responsibility to ensure compliance with Health Authorities requirements, the internal standards, and full adherence to patients’ safety, rights, and well‑being.
Major Accountabilities
- Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring considerable organization awareness (e.g., interrelationship of departments and business priorities).
- Drive implementation of quality strategy within Global Clinical Team (GCT)/ Clinical Trial Team (CTT) under responsibility.
- Regularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studies.
- Ensure adequate oversight of proactive quality risk management processes in the overseen areas, including quality risk assessments and submission/inspection readiness activities, and ensure that Clinical Trial Process (CTP) are in control.
- Provide robust and clear quality oversight in the following areas of clinical development: support/collaborate with key stakeholders (e.g., Country Development Quality (CDQ), Development Units (DUs), GCT and/or CTT members) to ensure that risks are detected and remediated; support core governance for quality incident management for critical and major deviations pertinent to the programs being assigned and ensure timely escalation when required; provide Good Clinical Practice (GCP) guidance to day‑to‑day questions arising from Clinical trials deliverables; collaborate with Country Development QA and External Service Providers (ESP) QA to drive initiatives relevant to internal monitoring and outsourced activities quality oversight; lead inspections preparation and facilitation in collaboration with other QA groups within Research & Development Quality (RDQ); support audits and inspections follow‑up activities including Corrective & Preventive Actions (CAPA) preparation.
- Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
- Active participation in continuous improvement initiatives (including workstreams) and ensure that areas identified as weaknesses are properly addressed and executed for sustainability.
- Be QA point of contact for the defined trials and attend meetings to ensure quality is embedded in decision‑taking processes.
Essential Requirements
- Bachelor’s degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/PharmD/Masters).
- Extensive experience in regulated activities (GCP/Pharmacovigilance) and clinical development and/or QA positions with strong understanding of clinical trials.
- Broad understanding of global expectations of Health Authorities in Clinical Development and profound understanding of the science of product development.
- Ability to work independently and in a global/matrix environment.
- Experience in managing projects.
- Strong skills in GCP, quality and/or clinical development.
Benefits and Rewards
Learn about all the ways we’ll help you thrive personally and professionally.
Clinical Quality Assurance - Program Lead (Associate Director) in London employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of London or Dublin. Our commitment to employee growth is evident through continuous learning opportunities and a supportive environment that prioritises patient safety and well-being. Join us to be part of a team that not only drives quality in clinical trials but also values your contributions and career development.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Quality Assurance - Program Lead (Associate Director) in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you answer questions more confidently and show that you're genuinely interested in the role.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms to get comfortable with common interview questions. The more you practice, the more natural you'll feel during the real deal.
✨Tip Number 4
Don't forget to follow up after interviews! A simple thank-you email can go a long way in leaving a positive impression. Plus, it shows your enthusiasm for the position and keeps you on their radar.
We think you need these skills to ace Clinical Quality Assurance - Program Lead (Associate Director) in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Clinical Quality Assurance - Program Lead. Highlight your relevant experience in GCP and clinical development, and don’t forget to showcase any leadership roles you've had in quality oversight.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in clinical trials and how your background aligns with our mission at StudySmarter. Keep it concise but impactful!
Showcase Your Skills:In your application, be sure to highlight your skills in quality risk management and your understanding of Health Authorities' expectations. We want to see how you can contribute to our team and drive quality initiatives.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Novartis UK
✨Know Your Stuff
Make sure you brush up on your knowledge of Good Clinical Practice (GCP) and the latest trends in clinical development. Familiarise yourself with the specific requirements of the role, especially around quality oversight and risk management processes. This will show that you're not just interested in the position but also understand the nuances of the industry.
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate your ability to lead and influence teams. Prepare examples from your past experiences where you've successfully driven quality initiatives or managed projects. Highlight how you collaborated with stakeholders to ensure compliance and patient safety, as this is crucial for the role.
✨Ask Insightful Questions
Interviews are a two-way street, so come prepared with thoughtful questions about the company's quality strategy and how they handle inspections and audits. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your values and career goals.
✨Be Ready for Scenario-Based Questions
Expect to face scenario-based questions that test your problem-solving skills in real-world situations. Think about potential quality incidents you might encounter and how you would address them. Practising these scenarios can help you articulate your thought process clearly during the interview.
