Overview
Clinical Quality Assurance – Program Lead. Location options: London, UK; Dublin, Republic of Ireland; Barcelona, Spain; Basel, Switzerland. ROLE TYPE: Hybrid Working. 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 authority requirements, internal standards, and patient safety, rights and well-being.
Responsibilities
* Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring awareness of interdepartmental relationships 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 processes 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 clinical development areas, including:
o Support/collaborate with key stakeholders (e.g., Country Development Quality (CDQ), Development Units (DUs), GCT and/or CTT members) to ensure risks are detected and remediated.
o Support core governance for quality incident management for critical and major deviations and ensure timely escalation when required.
o Provide Good Clinical Practice (GCP) guidance to day-to-day questions arising from Clinical trials deliverables.
o Collaborate with Country Development QA and External Service Providers (ESP) QA to drive initiatives relevant to internal monitoring and outsourced activities quality oversight.
o Support inspections preparation and facilitation in collaboration with other QA groups within Research & Development Quality (RDQ).
o 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.
* Participate in continuous improvement initiatives (including work streams) to address weaknesses for sustainability.
* Serve as QA point of contact for defined trials and attend meetings to ensure quality is embedded in decision-making processes.
Essential Requirements
* Bachelor’s degree in life science or healthcare field required. Advanced degree or equivalent education in life sciences/healthcare (PhD/MD/PharmD/Masters) preferred.
* 7 years of involvement in regulated activities (GCP / Pharmacovigilance), clinical development and/or QA positions.
* Broad understanding of global Health Authority expectations in Clinical Development and strong understanding of the science of product development.
* Ability to work independently and in a global/matrix environment.
* 3 or more years of project management experience.
* Strong skills in GCP, quality and/or clinical development.
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