The Development Quality Assurance Manager is responsible for assuring quality over-sight for activities undertaken in all entities in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines to assure the execution of high quality research and activities within a country(ies).
You will also be responsible for assuring the quality and compliance of Development, Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local Development colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs), Medical Affairs and Country QA to ensure compliance to entities requirements and relevant HA regulations and guidance.
Requirements:
Your key responsibilities, but not limited to:
Overseeing implementation, maintenance, and monitoring of the local Quality System and written procedures to ensure GCP and Pharmacovigilance related processes and tasks are compliant with global requirements and applicable regulations and guidelines.
Supporting and monitoring implementation of the local Quality Plan (QP) deliverables related to GCP and PV areas, ensuring alignment with the applicable global QP chapters where ever possible.
Ensuring adequate training systems are in place in assigned country(ies) for GCP, GPvP and other relevant.
Assuring that relevant business areas are maintaining inspection-ready documentation to support reviews of training compliance.
Driving Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable. Taking accountability for escalation of GCP/GPvP process non-compliance as needed.
Partnering with local and global Development teams, PS, NCQ and other internal stake-holders in the execution, where QA processes are subject to the audit, and follow-up of audits on clinical development and PV activities.
Acting as local approver for the documentation and management of local CAPAs to sup-port appropriate review and closure of each corrective and preventive action. Assuring local line functions take appropriate ownership of duties as required by the CAPA processes.
Desirable requirements:
Fluency in English (both written and oral)
At least 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance.
Preferably at least 3 years experience in clinical development.
Experience in leading projects.
Your key responsibilities, but not limited to:
Overseeing implementation, maintenance, and monitoring of the local Quality System and written procedures to ensure GCP and Pharmacovigilance related processes and tasks are compliant with global requirements and applicable regulations and guidelines.
Supporting and monitoring implementation of the local Quality Plan (QP) deliverables related to GCP and PV areas, ensuring alignment with the applicable global QP chapters where ever possible.
Ensuring adequate training systems are in place in assigned country(ies) for GCP, GPvP and other relevant.
Assuring that relevant business areas are maintaining inspection-ready documentation to support reviews of training compliance.
Driving Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable. Taking accountability for escalation of GCP/GPvP process non-compliance as needed.
Partnering with local and global Development teams, PS, NCQ and other internal stake-holders in the execution, where QA processes are subject to the audit, and follow-up of audits on clinical development and PV activities.
Acting as local approver for the documentation and management of local CAPAs to sup-port appropriate review and closure of each corrective and preventive action. Assuring local line functions take appropriate ownership of duties as required by the CAPA processes.
Desirable requirements:
Fluency in English (both written and oral)
At least 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance.
Preferably at least 3 years experience in clinical development.
Experience in leading projects.
This position is open to all candidates.
