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 competitive salary, hybrid work, 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 trials.
- Qualifications: Bachelor's degree in life sciences; experience in clinical development or QA preferred.
The predicted salary is between 70000 - 90000 £ per year.
Employment Type: Full‐time | Regular, Hybrid
Location: London (The Westworks) or Dublin (NOCC). 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.
Role Overview
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 the Health Authorities requirements, the internal standards and a 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 process 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 Work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability.
- Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the 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 of involvement in regulated activities (GCP / Pharmacovigilance (PV)), clinical development and/or QA positions with strong understanding on clinical trials.
- Broad understanding of global expectations of Health Authorities in the area of 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 Farmacéutica
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 comprehensive training programs and opportunities for advancement, ensuring that you can thrive both personally and professionally while contributing to meaningful clinical developments that prioritise patient safety and well-being.
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 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. Tailor your answers to show how your experience aligns with their values and goals. We want you to shine!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. The more comfortable you are, the better you'll perform when it counts.
✨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) 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 trials, and don’t forget to showcase any leadership roles you've had in QA. We want to see how you can bring value to our team!
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 needs. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Achievements:When detailing your experience, focus on specific achievements rather than just listing duties. Use metrics where possible to demonstrate your impact in previous roles. We’re looking for results-driven individuals who can make a difference!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Novartis Farmacéutica
✨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. 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 strong leadership capabilities. Prepare examples from your past experiences where you've successfully led teams or projects, particularly in a QA context. Highlight how you’ve driven quality strategies and managed risks effectively.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about the company’s quality strategy, their approach to clinical trials, and how they handle compliance with health authority regulations. This not only shows your interest but also helps you gauge if the company aligns with your values.
✨Be Ready for Scenario-Based Questions
Expect to face scenario-based questions that assess your problem-solving skills in real-world situations. Think about potential challenges in clinical trials and how you would address them. Practising these scenarios can help you articulate your thought process clearly during the interview.
