Head of Performance, Insight and Transformation

Job Title: Head of Performance, Insight, Innovation for Quality Audit, Inspection, Intelligence and Advocacy

Location: Framingham, MA

About the Job

We 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.

Your job, as Head of Performance, Insight and Transformation within our Innovation for Quality Audit, Inspection, Intelligence and Advocacy group will be to foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy.

This exciting role leads a team that is both the “backbone” and “transformation engine” of the Sanofi Quality Audit Inspection Intelligence & Advocacy team.  The team drives performance through data insights and transforms Sanofi's practice of auditing.  This team includes Business Process Owners for audit, self-inspection, received audits, and inspections for the Sanofi Enterprise across all GXP regulated areas and GBUs.  It is the home of our processes for auditing, centralized audit program, performance data, innovation roadmap, and the hub of our operations for departmental meetings and communications. 

This critical leadership role:

• Leads an international team that is both “backbone” and transformation engine for quality audit and inspection.

• The team is comprised of:

  • Business Process Owners (BPOs) for Audit, Self-Inspection, Inspection, Received Audits.  The BPOs ensure standardization and consistency across the Enterprise and work with Centers of Expertise and Practice (COE, COP). They also serve as a bridge between governance and enterprise for continuous improvement.

  • Quality Audit Insights Leader who applies business understanding, data analytic skills and teamwork to produce analyses for quality audit, inspection topics to drive performance and continuous improvement.

  • Quality Audit Futurist who applies foresight and experimentation to quality audit, inspection topics to transform and modernize our practices of quality audit, inspection. 

  • Quality Audit and Inspection QMS Manager who owns the department’s internal quality management system (e.g., training matrix, process documents, etc.) and publishes the department’s annual audit program.

• All Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI to launch, and commercial activities (including post-authorization changes). 

• GXP areas of Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP).

• Diverse product portfolio across all GBUs; Specialty Care, Vaccines, General Medicines.

• International scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products Administration (China), PMDA (Japan), ANVISA (Brazil).

• Is a core member of the Sanofi Quality Audit Inspection Intelligence and Advocacy Leadership Team. 

• May perform Quality Audits and / or support Regulatory Inspections.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Provides oversight on integrated audit and inspection performance data.

• Through collaboration with the Quality Audit, Inspection, Intelligence & Advocacy Leadership Team and key stakeholders, develops and implements the 3–5-year departmental transformation plan. 

• Experiments across strategic, tactical, operational activities for department and oversees pipeline of experimentation initiatives.

• Develops and implements communication strategy for Quality Audit, Inspection, and Intelligence Department

• Engages with other auditing functions in Sanofi.

• Management: Lead international team of ~05 quality professionals in Americas, Europe, complemented by year-round presence of students.

• Latitude of action: Highly independent and creative with thoughtful risk taking and compliance mindset.

• Role impa