At a Glance
- Tasks: Lead quality assurance for clinical trials, ensuring compliance and patient safety.
- Company: Join Novartis, a global leader in healthcare innovation.
- Benefits: Enjoy a competitive salary, hybrid work options, and personal development opportunities.
- Other info: Dynamic role with opportunities for growth in a collaborative environment.
- Why this job: Make a real impact on patient care through quality oversight in clinical research.
- Qualifications: Bachelor's degree in life sciences; experience in clinical development or QA required.
The predicted salary is between 70000 - 90000 € per year.
Employment Type: Full‑time | Regular, Hybrid
Location: London (The Westworks) or Dublin (NOCC)
Relocation: Novartis is unable to offer relocation support for this role. Please only apply if the locations of Westworks, London or Dublin are accessible for you.
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) 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)
✨Tip Number 1
Network like a pro! Reach out to people in your field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We want you to show how your values align with theirs, especially in quality assurance and patient safety.
✨Tip Number 3
Practice common interview questions related to clinical trials and quality oversight. We recommend doing mock interviews with friends or mentors to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Clinical Quality Assurance - Program Lead (Associate Director)
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 the perfect fit for this position. Mention specific experiences that align with the job description and show us your passion for ensuring patient safety and compliance.
Showcase Your Skills:In your application, make 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 quality strategy and improve clinical trial processes.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re serious about joining our team at StudySmarter.
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 strategies or managed projects. Highlight how you collaborated with stakeholders to ensure compliance and patient safety.
✨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 but also gives you a better understanding of their expectations and culture.
✨Be Ready for Scenario-Based Questions
Expect to be asked how you would handle specific situations related to quality assurance and clinical trials. Think through potential scenarios beforehand, such as managing a major deviation or preparing for an inspection. This will help you articulate your thought process and problem-solving skills effectively during the interview.
