Clinical Quality Assurance - Program Lead Associate Director

Novartis AG; City of Westminster; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company seeks an Associate Director for Clinical Quality Assurance to provide quality oversight for clinical trials, ensuring compliance with regulatory standards and patient safety. The role involves QA leadership, quality strategy implementation, and proactive risk management. Candidates should possess a Bachelor's degree in life sciences, 7 years in regulated activities, and strong project management skills. This position is based in Westminster, UK.

Qualifications

• 7 years of experience in regulated activities (GCP/Pharmacovigilance) and clinical development.
• Ability to work independently in a global/matrix environment.
• Strong project management experience (3 or more years).

Responsibilities

• Provide QA leadership to the business strategy for assigned programs.
• Drive implementation of quality strategy within Global Clinical Team.
• Ensure oversight of proactive quality risk management processes.

Skills

GCP

Quality Assurance

Clinical Development

Education

Bachelor's degree in life science or healthcare

Advanced degree in life sciences/healthcare

Job description

Overview

The Associate Director, Clinical Quality Assurance (QA) 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.

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 responsibility.
• Regularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studies.
• Ensure 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 control.
• Provide 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.
• Lead 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 addressed and executed for sustainability.
• Be QA point of contact for the defined trials and attend meetings to ensure quality is embedded in decision-making processes.

Qualifications

• 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), 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 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.