Specialist - Quality Operations

As the Special - Quality Operations at Novartis, your role involves overseeing the quality aspects of contract manufacturers for drug product/drug substance/intermediate product/raw material of ADACAP. You will be responsible for ensuring compliance with applicable ADACAP and Novartis standards, quality management systems, and relevant guidelines. Your key responsibilities include: - Developing and maintaining Quality Assurance Agreements with external partners - Qualifying and onboarding contract manufacturers, conducting regular quality risk assessments - Managing activities related to quality processes such as deviations, complaints, recalls, and stability failures - Reviewing third party documents from a quality perspective - Coordinating GMP documentation and compiling product quality reviews - Supporting quality improvement projects and general quality functions - Escalating significant quality incidents and supply risks - Implementing and maintaining a local Quality System and Standard Operating Procedures Your essential requirements for this role include: - Minimum 6 years of experience in pharmaceutical quality assurance, quality control, or manufacturing - Minimum 3 years of experience in a Quality Assurance function - Thorough knowledge of cGMP requirements and their practical application - Proven track record of maintaining quality oversight on external partners - Good communication skills and ability to make authoritative decisions Desirable requirements: - Higher university degree in Pharmaceutical, Chemistry, Biochemistry, or related science - Fluency in speaking and writing English Novartis is dedicated to creating an inclusive work environment and diverse teams that reflect the patients and communities they serve. Join us in reimagining medicine and improving lives. Learn more about our mission and values here: [Novartis Mission](https://www.novartis.com/about/strategy/people-and-culture) You can explore the benefits and rewards offered by Novartis in the Novartis Life Handbook: [Novartis Benefits & Rewards](https://www.novartis.com/careers/benefits-rewards) If you are interested in staying connected with Novartis for future career opportunities, consider joining the Novartis Network: [Join Novartis Network](https://talentnetwork.novartis.com/network) Novartis values collaboration and innovation to achieve breakthroughs that impact patients" lives positively. Join our community to create a brighter future together: [Join Novartis Community](https://www.novartis.com/about/strategy/people-and-culture),