### **Summary** * Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures ### **About the Role** **Major accountabilities:** * Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance \-Support exception investigations \-Review and approval of production, QC, and AS and T records \-MBR review \-Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration \-Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \-Distribution of marketing samples (where applicable) **Key performance indicators:** * On\-time and GMP\-compliant release of dosage forms \-No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand. * Successfully Support continuous improvement Projects \-Executes batch release in compliance with registration **Minimum Requirements:** **Work Experience:** * Critical Negotiations. * Functional Breadth. * Project Management. * People Leadership. * Collaborating across boundaries. * Operations Management and Execution. **Skills:** * Continuous Learning. * Dealing With Ambiguity. * Employee Performance Evaluations. * Gmp Procedures. * People Management. * Qa (Quality Assurance). * Quality Control (Qc) Testing. * Quality Standards. * Self Awareness. * Technological Expertise. * Technological Intelligence. **Languages :** * English. **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 Innovative Medicines Location Mexico Site INSURGENTES Company / Legal Entity MX06 (FCRS \= MX006\) Novartis Farmacéutica S.A. de C.V. Functional Area Quality Job Type Full time Employment Type Regular Shift Work No ### **Accessibility and accommodation** Novartis is committed to work with and provide 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.