岗位描述
职位描述
-Provide Leadership and manage Quality Assurance Managers in all quality related matters and to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual and Policies.- Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards.
主要职责
Major Accountabilities: Critical Negotiations, People Leadership, Operations Management and Execution, Collaborating across boundaries, Project Management Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receiptDistribution of marketing samples (where applicable)Key performance indicators: Successful support of projects with agreed quality & delivery dates, passing of internal and external inspections.Meet quality & timelines for all projects.Act in accordance with GMP, ethical, health safety and environment (HSE), and information security (ISEC).The number and severity of cGMP issues identified during internal and external audits.Year-end figures within budget.Background (State the preferred education and experience level)Education & QualificationUniversity degree in Pharmacy, Engineering, Chemistry, Biotechnology orequivalent.LanguageFluent (oral and written) in English; local language desiredRelevant ExperienceMinimum: 12-15 years’ experience in the field of Quality Assurance and Quality Control in a pharmaceutical industry environment or equivalentOperations Management and Execution, People Leadership, Collaborating across boundaries, Functional Breadth, Project Management, Financial Management, Industry/ Business ExposureCompetenciesCollaboration; result-orientedAdvanced communication skills; motivates colleagues and co-workersLeadership and change management, objective setting and performance managementBeing Resilient; Stakeholder Engagement; Operational Excellence; Applied Business InsightsBudget management; Risk ManagementProduct Release; Audit Management; Health Authorities; Technical Launch and TransferKnowledge of GMP Quality Control (QC) Testing, Manufacturing Process/Product ExpertiseExpertise in GxP operations.