Join to apply for the Associate Director, Clinical QA role at Novartis Ireland6 days ago Be among the first 25 applicantsJoin to apply for the Associate Director, Clinical QA role at Novartis IrelandGet AI-powered advice on this job and more exclusive features.SummaryLOCATION: London, UK or Dublin, Rep of Ireland, Barcelona, SpainSummaryLOCATION: London, UK or Dublin, Rep of Ireland, Barcelona, SpainROLE TYPE: Hybrid WorkingThe Associate Director, Clinical 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.About The RoleKey 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 responsibilityRegularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studiesEnsure 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 controlProvide 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 sustainabilityBe QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision taking processes.Essential RequirementsBachelor’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 productdevelopment.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 developmentWhy NovartisHelping 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? https://www.novartis.com/about/strategy/people-and-cultureJoin Our Novartis NetworkNot 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: https://talentnetwork.novartis.com/networkBenefits And RewardsRead our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsWhy 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? https://www.novartis.com/about/strategy/people-and-cultureJoin 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: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsSeniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Novartis Ireland by 2xGet notified about new Associate Director Quality Assurance jobs in Dublin, County Dublin, Ireland.Dublin, County Dublin, Ireland 1 week agoAssociate Director - Quality Assurance LeadDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 8 hours agoDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 6 days agoQuality Assurance Manager/ Responsible PersonDublin, County Dublin, Ireland 2 days agoRegulation, Audit & Quality Assurance ManagerDublin, County Dublin, Ireland 2 weeks agoExternal Site Quality Lead - Biologics (m/f/d)Dublin, County Dublin, Ireland 21 hours agoExternal Site Quality Lead - Biologics (m/f/d)Carmanhall and Leopardstown, Dún Laoghaire-Rathdown, Ireland 21 hours agoAssurance Technology Risk & Quality ManagerDublin, County Dublin, Ireland 3 months agoAssociate Director, External Service Provider QADublin, County Dublin, Ireland 1 week agoAssurance Technology Risk & Quality ManagerDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 3 months agoDublin, County Dublin, Ireland 4 days agoDublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 3 weeks agoDunboyne, County Meath, Ireland 6 days agoDublin, County Dublin, Ireland 6 days agoDunboyne, County Meath, Ireland 4 weeks agoWe’re unlocking community knowledge in a new way. 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