Clinical Quality Assurance - Program Lead

Overview

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 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.
  • 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.
• Active participation in continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly addressed and executed for sustainability.
• Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision-taking processes.
• 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/PV), 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.

Qualifications Summary

Minimum requirements and key qualifications are listed above. For additional context, see responsibilities and expectations described in the sections above.