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 impact:  Best in class audit, inspection performance, and transforms practice of auditing.

Scope: Manufacturing & Supply, Research & Development, Global Regulatory Affairs, Digital, Global Quality organizations in Sanofi.

About You

Experience, Education, Soft Skills, Technical Skills, Languages

Basic Qualifications

Minimum master’s degree in science, pharmacy, engineering, data science, or equivalent with at least +12 years relevant experience in the pharmaceutical, biotech, medical device, or related industries. 

Previous experience as an auditor or inspector (minimum 3 years). 

Line management experience for teams based in Americas and Europe (minimum 5 years). 

Inclusive, transformational, pragmatic leadership and change management.

This role demands initiative, effective storytelling, knowledge, and experience in analytics, including measurement techniques and experimentation.

Experience with deploying eQMS platforms in Biopharma, and platforms such as Power BI (minimum 2 years).

Fluent English.

Preferred Qualifications

Experience across all GXP areas, with deep knowledge in one or two domains. 

Previous experience interfacing with Regulatory Authority Inspectors.

Member of International Society for Pharmaceutical Engineering (ISPE), BioPhorum, BSI, and/or Parenteral Drug Association (PDA) with working group experience in authoring guidance documents and/or white papers.

French speaking is a plus.

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.