Job Description
Clinical Development QA Manager
Essential Pharma are looking for a Clinical Development QA Manager who will be focusing on identifying and mitigating quality and compliance risks related to all aspects of clinical studies, adhering to Good Clinical Practice (GCP), Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), Good Manufacturing Practice (GMP), Good Distribution Practices (GDP) for clinical trial supplies and Good Pharmacovigilance Practices (GPvP) regulations and guidance, as well as leading internal site audits and external regulatory inspections. Apply today!
What You Will Do
1. Maintain quality strategy, which is in line and suitable for the business needs relating to Clinical Development activities.
2. Maintain a quality system in line with business needs. This will include, but is not limited to:
3. Develop and maintain a quality management System to support the clinical development activities within the pre-commercial business unit.
4. Drive the development and issuance of the necessary SOPs to cover best practices that supports clinical trial activities and processes in a timely manner.
5. Provide support for GCP, which will include co-ordination of audits of clinical sites, CROs and internal processes and relevant clinical documentation as re...