At a Glance
- Tasks: Lead quality assurance for clinical trials, ensuring compliance and patient safety.
- Company: Join a leading healthcare organisation focused on innovation and quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic role with global collaboration and continuous improvement initiatives.
- Why this job: Make a real impact in clinical development and improve patient outcomes.
- Qualifications: Bachelor's degree in life sciences; 7 years in clinical QA or development.
The predicted salary is between 60000 - 84000 £ per year.
Overview
As an Associate Director level, Clinical Quality Assurance - Program Lead within Clinical Quality Assurance, you will provide Quality oversight for the end-to-end clinical process for the clinical trials under responsibility to ensure compliance with Health Authorities requirements, internal standards and 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.
- Support 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 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.
- 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/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.
Qualifications Summary
Minimum requirements and key qualifications are listed above. For additional context, see responsibilities and expectations described in the sections above.
Clinical Quality Assurance - Program Lead in City of Westminster employer: Novartis AG
As a leading employer in the clinical development sector, we pride ourselves on fostering a collaborative and innovative work culture that prioritises employee growth and well-being. Our commitment to quality assurance not only ensures compliance with health authority standards but also empowers our team members to take ownership of their projects, driving meaningful impact in clinical trials. Located in a vibrant area, we offer competitive benefits, continuous learning opportunities, and a supportive environment that values diversity and inclusion.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Quality Assurance - Program Lead in City of Westminster
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We think you need these skills to ace Clinical Quality Assurance - Program Lead in City of Westminster
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✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Novartis AG that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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