Job Description

- Responsible for the oversight of quality processes (e.g. GMP/GDP) and their implementation within the country platform, especially for: o Transportation and warehousing activities o 3rd party business (e.g. local contract manufacturing activities, local opportunities, repackaging / relabeling), incl. quality assurance agreements (QAAs) and GMP/GDP audits o Local change management o Local Quality IT o Technical complaint handling & Quality related issue management incl. deviation management - Quality Release for under licensed manufacturing - Establishes and maintains local Quality Management System (Implementation in line with local regulations and global QMS) - Identifies gaps related to the Quality Management System and establishes mitigation measures - Represents Quality in Senior Management of the country (e.g. QMR) - Leads the Quality country organization and has interlinkage to local functions performing quality (e.g. GDP/GMP) relevant processes (e.g. SCM) - Acts as interface to Managing Director and Cluster Quality Head on country-related Quality topics for marketed products - Provides local support for Health Authority Inspections - Ensures correct staffing and takes efficiency measures into consideration - Ensures quality training (e.g. GMP /GDP) for the local organization - Ensures implementation of local regulatory requirements for commercial quality activities in close cooperation with Head of Regulatory Affairs & Technical Pharmacist - Escalate local regulatory requirements on quality (e.g. GMP/GDP) to global function - Review of PQRs for local contract manufacturer - Ensure incoming imported goods check including evaluation of shipping temperatures