Clinical Quality Assurance – Program Lead
Job ID REQ-10040952 | Jul 10, 2025 | Spain
Location: London, UK or Dublin, Ireland, Barcelona, Spain
Role Type: Hybrid Working, #LI-Hybrid
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 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 community of 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.com
Additional locations include Dublin (CPO, NOCC) and London (The Westworks). We are committed to diversity and an inclusive work environment.
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