Associate Director

Summary We are seeking for a GxP and Quality expert with strong management skills to direct cross-functional teams and with strong communication skills to interact with internal stakeholders and external parties on global level including Health Authorities In this role you will support the strong Novartis Quality Organization in managing GxP and Quality Incidents in a cross-functional end to end process on a global level Associate Director Global GxP Quality Incident ManagementLocation - HyderabadAbout the Role We are seeking for a GxP and Quality expert with strong management skills to direct cross-functional teams and with strong communication skills to interact with internal stakeholders and external parties on global level including Health Authorities In this role you will support the strong Novartis Quality Organization in managing GxP and Quality Incidents in a cross-functional end to end process on a global level Key Responsibilities Manage GxP Quality Incidents in an end to end process that require cross-functional guidance and coordination as well as alignment on global level to achieve consistent cross-functional decisions across multiple sites entities functions and countries Arrange and support the initiation of Health Authority communication on a global level Support the definition and drive the implementation of corrective and preventive measures related to GxP Quality incidents on global level this includes also market actions if required Facilitate creation of knowledge repositories and roll out of lessons learned facilitate the maintenance of global incident management processes and procedures Collaborate across functions in resolving GxP Quality Incidents and preventing recurrence Support related GxP Quality incident prevention activities across the entire organization Essential Requirements Multiple years approximately min 6 years of relevant thought experience in the pharmaceutical industry Quality Manufacturing or Development with strong experience in the Quality area GxP-Compliance Quality Assurance and or Control Experience in conducting end-to-end management of quality incidents Experience related to classical pharmaceuticals various dosage forms including steriles biologics and cell and gene therapy products thought understanding of pharmaceutical manufacturing processes analytical procedures as well as Quality Management systems knowledge of radio-ligand products and technology is favourable Knowledge in and experience with major international pharmaceutical regulations e g US FDA EMA Anvisa ICH WHO and with the related Health Authorities e g US FDA EMA PMDA TGA Anvisa Knowledge of and experience with ISO is favourable Good understanding of international pharmaceutical regulatory processes Strong analytical thinking Business fluent in English verbal and in writing Strong skills in applying IT tools and software programs like MS Excel Powerpoint Word etc Profound knowledge of pharmaceutical business in general Desirable Requirements University degree in the pharmaceutical live science field such as but not limited to a pharmacist biochemist microbiologist or other specialized biologist or chemist Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world How can we achieve this With our people It is our associates that drive us each day to reach our ambitions Be a part of this mission and join us Learn more here https www novartis com about strategy people-and-cultureYoull receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewardsJoin our Novartis Network If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here https talentnetwork novartis com network Skills Desired Agility Agility Auditing Audit Management Business Acumen Business Partnering Collaboration Teamwork Communication Skills Compliance Audits Continuous Learning Dealing With Ambiguity Decision Making Skills Employee Performance Evaluations Finance Acumen Gmp Procedures Goal-Oriented Health Authorities Inspection Readiness Leadership Logical Thinking Major Incident Management Organization Skills People Management Problem Solving Skill Problem Solving Skills 5 more