Clinical Quality Assurance – Program LeadJob ID REQ-10040952 | Jul 10, 2025 | SpainLocation:
London, UK or Dublin, Ireland, Barcelona, SpainRole Type:
Hybrid Working, #LI-HybridAs 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 clinical trials under your responsibility to ensure compliance with health authority requirements, internal standards, and full adherence to patient safety, rights, and well-being.About the Role
Key Responsibilities:
Proactively provide QA leadership to the business strategy for assigned programs/trials, ensuring organizational awareness of interdepartmental relationships and business priorities.Drive implementation of the quality strategy within the Global Clinical Team (GCT) / Clinical Trial Team (CTT).Monitor the implementation of the annual Quality Plan for assigned programs/studies.Ensure adequate oversight of quality risk management processes, including risk assessments and inspection readiness activities, ensuring Clinical Trial Processes (CTP) are in control.Support and collaborate with stakeholders (e.G., Country Development QA, Development Units, GCT/CTT members) to detect and remediate risks.Support governance for quality incident management, including deviations and escalation procedures.Provide GCP guidance for clinical trial activities and collaborate with external QA providers.Assist in inspection preparation and follow-up activities, including CAPA.Leverage audit/inspection outcomes to improve clinical trial conduct.Participate in continuous improvement initiatives, addressing weaknesses for sustainability.Act as QA contact for trials, attending meetings and embedding quality in decision-making processes.Qualifications:
Bachelor’s degree in life sciences or healthcare;
advanced degrees preferred (PhD, MD, PharmD, Master’s).Minimum 7 years in regulated activities (GCP, Pharmacovigilance), clinical development, or QA roles.Broad understanding of global health authority expectations in clinical development.Ability to work independently in a global/matrix environment.At least 3 years of project management experience.Strong skills in GCP, quality assurance, and clinical development.Why Novartis:
Helping people with disease and their families requires more than science;
it requires a communityof passionate, collaborative people committed to making a difference.Our Novartis Network:
If this role isn't the right fit, sign up for our talent community to stay connected and learn about future opportunities:
talentnetwork.Novartis.ComAdditional locations include Dublin (CPO, NOCC) and London (The Westworks). We are committed to diversity and an inclusive work environment.
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