As a result of an increase in workload we are now seeking a Quality Assurance Manager responsible for acting as the technical expert, an escalation point for complex and high impact issues and decisions.
Management of audit and inspection findings;
Develop and maintain a quality management plan;
Review and revise client PSMFs in collaboration with the QPPVs, as required;
Provide case quality verification and oversight including corrective action plans for cases not meeting quality standards;
Provide strategic plans for quality issues;
Assist in any investigating within the company including but not limited to the handling of deviations, complaints internally and at client sites;
Support in GMPD/GDP.ISO audits;
Support line manager on corrective actions for deviations/internal/external audits and CAPA’s;
Identify safety process efficiency/effectiveness issues and provide solutions for improvement;
Coordinate with the PV Operations Manager and Post-Marketing PV Manager to develop a training program.
Bachelor’s or higher graduate degree in a science related field, or equivalent experience.
Minimum of 2 years of experience in Quality Assurance;
Knowledge of quality assurance, audits under GPx (ISO is a plus) and implementation of KPIs to improve CAPA monitoring;
Knowledge in regulatory affairs/vigilances/life science domain and medical devices being a plus.
Ability to work, plan and lead projects in cross function team;
Flexibility in working on diverse projects;
Fluent in English and German for daily contact with internal and external partners, French is a plus.