Description
Our Global Pharmaceutical client has a fantastic reputation within the industry and multiple successful sites across the globe. For one of their largest manufacturing sites globally, they are searching for a QA director to lead the site in driving QA excellence.Role
• Assist in improvement of QA policy and strategic direction by providing consultation and recommendations to regional and Global QA Management.
• Oversee and manage the QA department within daily work including: team management, project management and delivery to milestones, routine QA documentation maintenance, data/metrics analysis.
• Serve as author for QA SOPs, ensure that operating procedures, work instructions and guidelines describing the processes applied by the department are maintained up-to-date to reflect current practice and are consistent with industry standards and regulations.
• Support the QA team through the introduction of a new QA documentation management system.
• Ensure appropriate preparation for, management of, and response to upcoming pre-approval and routine regulatory inspections in order to deliver the optimum outcome.
• Interface with Senior Management regarding quality/compliance and continuous improvement issues, as necessary.
• Conduct training within the QA department.
• Present trend analysis results and QA metrics to upper management; represent QA in senior management meetings.
Requirements
• Experience of management of a QA team in global pharmaceutical environment.
• Thorough understanding of daily running of a QA department including QA systems, metrics and reporting, investigations, inspections and deviations.
• Outstanding team management skills in a matrix organisation.
• Extensive experience in the pharmaceutical industry, ideally in a commercial manufacturing environment.
• Previous experience of hosting audits and extensive knowledge for FDA/GMP requirements.
• Ability to demonstrate exceptional communication skills; the job holder will be required to work closely with both internal and external stakeholders and should be capable of driving QA agenda.
• The successful candidate will be a driven individual, capable of driving a team to achieve the best results.
• English language skills essential, German language skills nice to have.