.Bayer Company, for its manufacturing site located in Alcalá de Henares (Madrid), currently undergoing expansion projects, with a strong investment plan for the following years, offers an opportunity as Quality Assurance Head.Position PurposeLead and supervise Quality Assurance Department activities (25+ people), assuring continuous compliance with applicable GxP/regulatory requirements in each country, with required operational effectiveness to assure an adequate on-time service to internal and external customers.Major Tasks and Responsibilities of the PositionAssures, coordinates and supervises site oversight activities under the scope of Quality Assurance Department.Supervise and manage batch review and approval process according to GMP/GDP principles (including oversight of QP function), PQR and OPV activities, assessment, writing and approval of investigation reports for deviations, OOS and complaints, and CAPA System.Oversight of qualification and validation for manufacturing, cleaning, computer systems and analytical methods, assuring proper support to Site projects (new products, equipment and facilities).Assures GMP compliance at site through Gemba, self-inspections, internal audits and Bayer guidelines implementation.Supervises and manages supplier qualification and certification system, training system (including annual training plan), Change control system, risk assessment and GMP documental management.Compile and carry out Quality Management Review (SQMR), monitor the corrective and preventive actions associated with it and coordinate Customer and Health Authorities inspections.Main Objectives of the FunctionPlays an essential role in making Quality a competitive advantage, driving strategies to assure quality, compliance and process robustness is an integral part of site DNA.Coordination of activities with different departments to assure Fit for purpose Quality Systems are in place.Analysis of compliance trends to identify gaps in the organization and establish action path towards inspection readiness.Relations with internal / external stakeholders.Key contact with Health Authorities during Inspections.Continuous cooperation with other internal and external functions (Global Quality, Supply Chain, Production, Engineering, IT).QualificationsDegree in Pharmacy, Chemist or similar studies. PhD will be valued.Long experience in pharmaceutical operations (10+ years) including team leadership.Experience in different Quality Assurance positions with deep knowledge of applicable GMP and Food legislation.Experience in operational positions within a pharmaceutical site.Strong interpersonal skills with a team-oriented mindset, instilling trust.Strong leadership (including lateral) and change management skills.Strong problem-solving, negotiation and communication skills.Operational management capabilities.Fluent in English
