Quality Operations Expert II

About The JobWe deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.Sanofi has added two new Modulus Facilities to our global industrial footprint. These production units represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.Fully digitalized, our Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. These facilities will help improve people’s lives by giving them faster access to more treatments.Main ResponsibilitiesEnsuring all batch release activities comply with Good Manufacturing Practices (GMP).Perform disposition of drug substance for releaseInvestigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product in case distribution channel face an unusual event)Leading root cause analysis investigations for quality incidents and implementing preventive measures.Collaborating with regulatory support officer to ensure compliance with local and international regulations.Participating in Quality Alert/Product alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lotsPoint of contact within operational team for complaint investigation when needed on site (coordination of investigation report).Business Process Owner for annual product quality reviewAct as change control assessor and QA approverImplementing continuous improvement initiatives to enhance deviation investigation and progress monitoring process and effectiveness.Participating in internal and external audits and inspections. ExperienceSkills and ExperiencesAt least 5 years of experience in a QA role within the pharmaceutical industry, with a focus on deviation management and batch release processesStrong knowledge of Good Manufacturing Practices (GMP) and quality assurance principlesSkillsCapability to investigate and resolve issues or deviations efficiently.Ability to meticulously review batch release documentation to ensure accuracy and compliance with regulatory standards.Proficiency in analyzing performance metrics and identifying areas for improvement.Experience in managing multiple tasks and projects simultaneouslyAgility to work in an ambiguous start up environmentnullPursue Progress. Discover Extraordinary.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.