The Opella Healthcare Global Audit Coordination Lead is a member of the CHC Audits and Inspections team within CHC Global Quality. The mission of our team is to define the CHC Global Quality Audit policy and to coordinate its implementation across the business and to provide an accurate, independent assessment of CHC sites, Development Centres, country offices, CDMOs, Pharmacovigilance and Suppliers for compliance with Sanofi CHC Quality Policy / requirements and applicable regulations through audit and inspection support activities. **Main responsibilities:** + Defines in cooperation with the Global CHC Audits and Inspection team, the CHC annual quality audit plan. Monitorsthe audit schedule and adaptsthe plan as necessary to support Quality / Business needs throughout the year. + Supports quality audit process implementation + Supports the qualification of auditors + Interacts regularly with manufacturing sites, commercial offices, and Third Party Management teams + Is a qualified auditor performing audits (periodic professional trips are expected in this role). + Provides expertise and support and enhances good practices for process simplification and improvement. + Ensures the accuracy of the database for CHC auditsand supports follow-up of audit observations and corrective actions + Consolidates key indicators for quality audit and performance statusand prepares summaries and presentations for senior leadership + Supports the evolution of the tools/systems related to the audits & inspections and act of Business Process Owner for some processes. _About you_ + **Experience** :5-10 yearsworking experience in Quality management in Pharmaceutical Industry and/or distribution. + **Technical skills:** + Good knowledge of GXP regulations and pharmaceuticals standards for a wide range of products (CHC Drug Products, Neutraceutical, Cosmetics, Medical Devices) + Be a qualified auditor, minimum experience of 5 years in a GMP/GDP environment. + Good knowledge in technical environment as of use of eQMS, databases, extraction models, KPI management + **Soft skills:** Organization,communication and presentation skills, networking capability, leadership and assertiveness skills. + **Education** :Pharmacist or Life Sciences Graduate (e.g., Bachelor,Master, PhD or equivalent) + **Languages** : English / French spoken and written compulsory. **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)