The Opella HealthcareGlobal Audit Coordination Leadis 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.

• 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.