ResponsibilitiesImplements and manages the required guidelines and cGMPs for the client, providingLEAN based Quality Systems and Tools, controlled, harmonized and aligned with thecompany's strategic plan, promoting a rigorous and continuous improvement cultureto guarantee high quality compliant sites. Maintains active and efficientcommunication channels along the several client sites, identifying Quality needsand improvements both from internal and external stakeholders. Evaluates, advisesand provides services and technical support, internally and externally, related to thelegal and scientific regulatory requirements in relation to product development,commercialization and optimization across the full product lifecycle to ensurecompliance with both global and local regulatory legislation, guidelines, inspections,audits and other regulatory due diligence. Represents the client throughcommunications and negotiations with regulatory authorities, preparing, submittingand managing all matters related to regulatory submissions and licensing forthe client and customer products; and within professional associations, industry/tradegroups.● Promote the importance of high-quality work levels and the importance of acontinuous improvement culture in all Quality and/or Regulatory Systemsactivities.● Advise and coach Team Members on complex issues which may impact / beimpacted by cGMP and/or ISO standards. Quality or Regulatory Systems andTools, promoting the right choices and resolution of issues that address theroot cause.● Lead initiatives with other departments, ensuring plan definition and timelyexecution● Review and approve Quality and/or Regulatory Systems and Tools relateddocumentation and training, preparing more complex documentation and tools● Respond in audits/inspections (Internal and of Health Authorities)● Open and maintain active and efficient communication channels along theseveral client Sites, identifying Quality or Regulatory needs andimprovements and addressing them● Manage other Corporate Systems key activities, such as delivering on theCorporate Quality or Regulatory KPI's, Corporate Quality or RegulatoryTraining, Quality and/or Regulatory Systems Management (e.g.,Documentation Management System), CAPA, Change Control, corporateanalytical electronic systems, filings, customer support etc.)● Master Quality Systems' processes and tools● Manage complex projects/ analysis with significant impact on business● Manage risk and uncertainty; anticipate and escalate roadblocks in order toprevent deviations to the goals.● Execute professional activities in compliance with Quality, Regulatory andHSE guidelines, internal and external requirements as well as promote theimplementation and maintenance of client policies, systems andprocedures (COPs, HBR, SOPs and others).Qualifications● University, or equivalent, qualification in Chemistry, Chemical Engineering,Pharmacy or similar scientific field (mandatory)● Typically requires 2-5 years of relevant overall experience in at least 2operational and support areas (e.g., Quality Control, Quality Assurance,Manufacturing, R&D, Engineering), preferably within the PharmaceuticalIndustry.● Advanced knowledge of Quality and/or Regulatory requirements, cGMP 's,ICH, CFR, EU, local or any other as applicable guidelines and ISO Standardsas applicable with the ability to solve complex problems.● Understanding of the business with a global insight on the company● Knowledge of industrial safety, lean6sigma, and risk assessment applied toQuality Systems● Must have the Knowledge, Experience and Skills to conduct their tasks inaccordance with the rules and procedures set down.● Fluency in English is a requirement● Computer literate with good working knowledge of the MS Office package
