Associate Director - Clinical Quality Assurance
Proclinical are excited to announce an Associate Director role specialising in Clinical Quality Assurance. This is a crucial role for a talented individual who can ensure the quality of all products.
- Proactively provide QA leadership to the business strategy for assigned trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities),
- Support implementation of quality strategy within GCT under responsibility.
- Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rational and appropriate escalation.
- 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 CTP processes are in control
- Participate in audits and inspections follow-up activities including CAPA preparation
- Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
- Support continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly being 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.
Skills and Requirements
- Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.
Fluency in English (oral and written)
- +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.
- 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.
- Strong interpersonal, communication, negotiation, and problem-solving skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Luke Saner at +443300524502 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies