Senior Clinical Quality Assurance Manager

Beschreibung

We have a new project for experienced clinical quality assurance manager to join a project to oversee the execution of clinical trials and compliance with the required regulations

Tasks:
provide QA leadership to the business strategy for assigned trials
Support implementation of quality strategies
monitor the implementation of the annual Quality Plan and ensure that all delayed activities have a documented rational and appropriate escalation.
Ensure adequate oversight of quality risk management process in areas such as quality risk assessments, submission/inspection readiness activities and ensure that clinical activities and processes are executed according the required standards
Establish/ lead core governance for deviation, incident management for critical or major deviations pertinent to the programs being assigned and ensure timely escalation when required
Provide regulatory guidance to day to day questions arising from Clinical trials deliverables
Collaborate with Development Operations QA to drive initiatives relevant to internal monitoring and outsourced activities Quality oversight
Support inspections preparation and facilitation in collaboration with other QA groups
Participate in audits and inspections follow-up activities including CAPA preparation
In collaboration with other QA functions, provide feedback learned from deviations/incidents, audits and inspections.
Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.

Requirements:
Strong experience in regulated activities (GCP/PV), clinical development and/or QA positions.
Broad understanding of global expectations of Health Authorities in Clinical Development and profound understanding of the science of product development.
Ability to work independently and in a global/matrix environment.
experience in managing projects.
Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
Strong skills in GCP, quality and/or clinical development.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.