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- Tasks: Lead quality assurance for clinical trials, ensuring compliance and patient safety.
- Company: Join Novartis, a community of passionate individuals making a difference in healthcare.
- Benefits: Hybrid working, competitive salary, and personal development opportunities.
- Why this job: Make a real impact on patients' lives through innovative clinical practices.
- Qualifications: Bachelor's degree in life sciences and 7 years in clinical QA or development.
- Other info: Collaborative environment with strong focus on continuous improvement and career growth.
The predicted salary is between 48000 - 72000 £ per year.
LOCATION: London, UK, Dublin, Rep of Ireland, Barcelona, Spain
ROLE TYPE: Hybrid Working.
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.
Responsibilities
- 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 & preventative 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).
- 7 years of involvement in regulated activities (GCP/ Pharmacovigilance (PV)), clinical development and/or QA positions.
- 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.
- 3 or more years’ experience in managing projects.
- Strong skills in GCP, quality and/or clinical development.
Clinical Quality Assurance - Program Lead (Associate Director) employer: Novartis
Contact Detail:
Novartis Recruiting Team
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 your connections in the clinical quality assurance field. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Familiarise yourself with their recent projects and challenges in clinical trials. This will help you tailor your responses and show that you're genuinely interested in contributing to their mission.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors. Focus on articulating your experience in GCP and quality oversight clearly. The more comfortable you are discussing your skills, the more confident you'll feel during the real deal.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you. Plus, it’s a great way to ensure your application gets noticed by the right people. Let’s get you that dream job together!
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 QA.
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 engaging and personal!
Showcase Your Achievements: When detailing your experience, focus on specific achievements rather than just responsibilities. Use metrics where possible to demonstrate your impact in previous roles, especially in managing quality processes or leading teams.
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 shows you’re keen on joining our community!
How to prepare for a job interview at Novartis
✨Know Your Stuff
Make sure you brush up on your knowledge of Good Clinical Practice (GCP) and the latest regulations in clinical development. Being able to discuss these topics confidently will show that you're not just familiar with the basics, but that you understand the nuances of the role.
✨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. This will help illustrate your capability to provide QA leadership effectively.
✨Understand the Company Culture
Familiarise yourself with Novartis' mission and values. They emphasise collaboration and community, so think about how your personal values align with theirs. During the interview, share how you can contribute to their culture and support their goals.
✨Prepare for Scenario Questions
Expect to be asked about specific situations you've faced in previous roles, especially regarding quality oversight and risk management. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively, showcasing your problem-solving skills.
