Summary Ensure that for all Novartis products - manufactured by external supplier in scope of personal portfolio - all aspects of manufacturing testing release and distribution import comply with international standards of GMP regulatory requirements the Novartis Group Quality Manual and the applicable Quality Agreements About the Role Key Responsibilities Acts according to Novartis values and behaviors Provides direction and formulates strategies to maintain and improve the external supplier quality oversight Establishes and maintains quality relationship with suppliers in scope Acts as Single Point of Contact SPOC for all quality related activities at assigned external suppliers Provides the quality presence and input to technical meetings with the external suppliers and establishes good working relationships External supplier quality related activities are further described in the subsequent paragraphs Conducts all necessary trainings in due course to be suitably qualified to perform the assigned duties Supplier qualification Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks Ensures site readiness for regulatory inspections and quality audits and supports during such events Routine monitoring Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews Critically assesses the performance of the product and process performed at the external supplier Escalate any issues or instances of instability as necessary Implements and monitors Key Performance Indicators KPI and ensures that all parts of ESO are working in a consistent manner against harmonized expectations Initiates corrective actions when necessary and performs follow-up on resulting measures Maintains relevant data bases in a timely manner with accurate information Incident management Manages all quality issues complaints deviations OOX Ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion Escalates and represents cases within the Novartis quality escalation process Change controls Ensures that change requests either from the external supplier or from Novartis are managed appropriately from receipt through to the implementation and closure Manufacturing process and analytical methods transfers Ensures QA Oversight during commercial product transfers Ensures knowledge transfer for secure commercial manufacturing operations Supports the establishment of continuous process verification programs Essential Requirements Min 8 years of experience in in the pharmaceutical industry Min 5 years of experience in the manufacturing of sterile pharmaceuticals Expert knowledge in aseptic sterile pharmaceutical processes and manufacturing of biologics Min 5 years of experience in operational quality assurance Expert knowledge of cGMP requirements for major regulated markets EU US Advanced experience with FDA EMEA and other Health Authorities Expert in risk management Advanced understanding of project management Expert in communication and advanced negations skills Advanced decision-making skills Basic leadership skills Why Novartis Helping people with disease and their families takes more than innovative science It takes a community of smart passionate people like you Collaborating supporting and inspiring each other Combining to achieve breakthroughs that change patients lives Ready to create a brighter future together https www novartis com about strategy people-and-culture Join our Novartis Network Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up https talentnetwork novartis com network Benefits and Rewards Read our handbook to learn about all the ways we ll help you thrive personally and professionally https www novartis com careers benefits-rewards Division Operations Business Unit Universal Hierarchy Node Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Functional Area Quality Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to email protected and let us know the nature of your request and your contact information Please include the job requisition number in your message Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve