The Quality Assurance Manager will support the development and implementation of a global quality assurance department.
The QA Manager will be responsible for performing key Quality Management Systems (QMS) tasks in respect of company products. Work in the Quality department, close interactions with Pharmacovigilance, Regulatory Affairs, Clinical Development, Supply Chain, CMC Regulatory Affairs.
Reporting to the Head of Global Quality.
- Responsible for maintaining appropriate compliance with GxP activities focusing on GVP, GLP and GCP.
- Support Global Pharmacovigilance, Regulatory Affairs, Clinical Development, Supply Chain, CMC Regulatory Affairs’ teams to ensure that QMS is compliant with applicable Global and EU regulatory requirements.
- Development and management of components of the QMS, which consists of, but not limited to: change control, deviations, CAPA's, procedures, training, complaints, documentation, audits, inspections and vendor management.
- Implement and improve QMS to the highest quality standards attainable for all activities conducted by the company.
- Proactive in continuous improvement opportunities within the QMS.
- Be a key member during regulatory inspections and internal and external audits.
- Compile and manage Quality metrics and KPIs.
- Be an active member of the global communication network; participate in monthly meetings with key stakeholders.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Ability to establish working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds. Required/Preferred Education and Licenses
- Degree in Life Sciences.
- Minimum 5 years’ experience in Biotech, Pharma or Clinical Research Organization.
- Understands and maintains strong working knowledge of GxP, global regulations and guidelines for pharmaceutical companies.
- Good operational knowledge, including experience in GVP, GCP and GMP audits and inspections
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