Clinical Quality Assurance – Program Lead

Location: London, UK; Dublin, Republic of Ireland; Barcelona, Spain

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 Authorities requirements, internal standards, and a full adherence to patients’ safety, rights and well-being.

Key Responsibilities

• Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring broad organizational 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 in overseen areas, including quality risk assessments and submission/inspection readiness activities; ensure 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, Development Units, 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 trial 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 & 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) and ensure that areas identified as weaknesses are properly addressed and sustained.
• Be QA point of contact for the 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/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 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’ experience in managing projects.
• Strong skills in GCP, quality and/or clinical development.