Clinical Quality Assurance - Program Lead
Summary
LOCATION: London, UK, Dublin, Rep of Ireland or Barcelona, Spain
ROLE TYPE: Hybrid Working, #LI-Hybrid
About the Role
Key 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 & 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
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
Recommended Jobs
L3 Early Years Educator in Putney
A diverse and friendly nursery in Putney is now looking for a caring and passionate L3 Early Years Educator to join the dedicated team of staff, to start as soon as possible. A Level 3 Ear…
Independent Sexual Violence Advocate
Independent Sexual Violence Advocate Contract: 3-month, full-time fixed-term contract Location: Remote/hybrid, with some office presence in London Salary: £32,000 per annum Please note: Th…
Care Logistics Lead
Care Logistics Lead £29,412 - £35,412 (including London Allowance) plus benefits 37.5 hours per week, Monday - Friday 9am - 5pm London, E12 5DA We’re looking for an ambitious logistics pr…
Members Club Host/ess
As a Host at Six Senses Place, I fully embrace the vision of Six Senses to help people reconnect with themselves, others, and the world around them. I will bring to life our values of local sensitivi…
Stadium Logistics Operative
We are expanding our logistics team to work with us at Charlton Athletic Football Club. We are seeking reliable and hardworking Logistics Operatives to join our matchday and events team. This vital…
Trade Marketing Intern
Liberty London is seeking a passionate, detail-oriented Trade Marketing Intern to join our Fabrics Team. This is an exciting opportunity to work with one of the world’s most iconic brands, supporting…
Business Planning & Treasury
Produce and update the Group's long-term business plan and assess impacts of new investments and risks. Manage statutory and management accounts for the financing subsidiary. Oversee daily trea…
Systems Engineer - City of London
Systems Engineer - City of London Introduction Saab UK is part of Scandinavia's largest defence company, bringing together the best of Swedish and British innovation. Saab offers world-leading so…
National Field Sales Manager
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All . We are proud to be a Top 10 player in the European Consumer Self…
Head Registered Veterinary Nurse
Job Role Overview: We are seeking an experienced and dedicated Head Registered Veterinary Nurse to join our team in Roehampton, Greater London . As part of our vibrant and growing veterinary pr…