Quality Responsible Person

at  Sanofi US

EXPERIENCE:

• Minimum 2 years of pharmaceutical experience in similar position, with in-depth knowledge of the Regulatory and Legal aspects of the business
• Previous Quality Assurance experience is a plus

SOFT SKILLS:

• Ability to build sound relationship with Healthcare and Regulatory bodies
• Capacity to work as part of a team, respecting the needs, contributions and opinions of others and ability to build relationships across affiliate, departments, and functions
• Very good communication and negotiation skills
• Flexibility and tenacity in complex and changing environment
• Able to take timely and effective decisions using innovation and initiative

TECHNICAL SKILLS:

• Knowledge of pharmaceutical legislation
• Knowledge of quality standards
• Computer literacy

EDUCATION:

• Faculty of Pharmacy - Professional certification according to local regulations

IF THE DESCRIPTION FITS YOUR EXPERIENCE AND HAS AROUSED YOUR INTEREST, WE ENCOURAGE YOU TO APPLY SO WE CAN GET IN CONTACT WITH YOU!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.
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, disability, or gender identity.
Pursue Progress, Discover Extraordinary

• Ensure that suppliers and customers involved in distribution activities, including pharmacies and hospitals, are approved and licensed, enhancing collaboration and quality assurance
• Contribute to the approval process for subcontracted activities impacting distribution, ensuring efficiency and compliance
• Manage affiliate quality system implementation, emphasizing adherence to GxP standards and health regulations, ensuring product integrity
• Ensure required quality documents are in place, in-use and up to date at country level for GxP areas
• Participate in quality audits and regulatory inspections, ensuring continuous readiness and compliance
• Contribute to annual Affiliate Quality Review, fostering continuous improvement and adherence to ISO 9001:2015 requirements
• Participate in Corrective and Preventive Action (CAPA) management, mitigating risks and improving quality processes
• Contribute to the definition and rolling-out of the annual quality program endorsed by senior management
• Contributes to proactive and reactive quality risk management matters within the affiliate (identification, assessment, control, communication)
• Be involved in the management of product complaints received by the affiliate according to company processes, standards and appropriate tools in force, in connection with the operational quality unit in charge of affiliates and the concerned Global Quality function, as appropriate
• Identify, collect and report adverse events and safety information to the Affiliate Pharmacovigilance Unit, ensuring product safety and compliance with local procedures