Global Head of Quality Audit and External Liaison

Job title:

Global Head of Quality Audit and External Liaison

Location:

Remote, USAbout the Job The team vision is to become catalysts for providing risk based, predictive & objective assurance, insight, support, intelligence & The team vision is to become catalysts for positive change by identifying the unseen, providing risk based, predictive & objective assurance, insight, support, intelligence & advocacy.

The mission is to foster best in class performance by leveraging data, technology, and diverse talents to secure product launches and support compliance through quality audits, regulatory inspections, regulatory surveillance and advocacy. Core values are integrity, collaboration, innovation and expertise.

The team is comprised of ~40 people in 7 countries in USA, Euro Scope Includes All Good X Practice (GXP) domains;
Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and Data Integrity. Technology, including medical devices, computerized systems, in-vitro diagnostic (IVD) and digital technologies including artificial intelligence. Diverse product portfolio;
Specialty Care, Vaccines, General Medicines, Consumer Health Care (until completion of Transition Agreement). Lifecycle activities for products including pre-authorization to submission, submission to launch, commercial (including post-approval commitments and post-approval changes), additional indications (line extensions), divestments, Pharmacopoeia Affairs (USA, Europe, China). Legislative lifecycle activities including development of new legislation, evolution of existing legislation, interpretation/enforcement of legislation

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system — and innovative pipeline — enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main Responsibilities Design, develop and implement the department roadmap.

Risk-based auditing strategies, tactics, and operations across GXP. External engagement for intelligence and benchmarking, and advocacy for Sanofi critical topics. Regulatory Inspection Activities for routine and Pre-Approval Inspections by International Regulators. Support due diligence and reverse due diligence activities. Utilize data, technology to drive efficiencies, enhance insights, facilitate knowledge sharing, and simplify. Represent Sanofi externally at key industrial and trade association meetings and in working groups.

Foster a culture of quality and cGMP compliance, engaging all organizational levels to drive continuous improvement. Latitude of action:
Highly independent with thoughtful risk taking and compliance mindset. Role impact: continued right to operate for marketed products. Scope:
Manufacturing & Supply, Research & Development, Digital, Pharmacovigilance, Commercial, Countries, as well as interfacing with other Auditing and Compliance organizations in Sanofi.

About You Basic Qualifications
15+ years relevant experience in the pharmaceutical, biotech, medical device, or related industries or a major regulatory authority. Strong experience with regulatory and pharmaceutical policy.

Inclusive, transformational, pragmatic leadership and change management. Fluent English. Bachelors degree in a related science…