Compliance Head, U.S. FDA

Job Title: Compliance Head- US FDA

Location: Framingham, MA, Morristown, NJ 

Job Title: Compliance Head- US FDA

Location: Framingham, MA, Morristown, NJ 

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. 

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.  Grounded in core values Integrity, Collaboration, Innovation, Expertise.

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:

·  Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up for US FDA exposed sites within Sanofi and the external network (e.g., CMOs, Alliance Partners, etc.):

• Enhance inspection readiness through on-site quality system assessments, audits, identifying gaps, and developing mitigation action plans.

• Oversee FDA inspection preparation, providing guidance, training, and coaching to ensure thorough readiness and effective response management.

• Provide direct support to US FDA GMP inspections on-site to ensure successful outcomes.

• In collaboration with the sites, coordinate and prepare briefing materials for US FDA inspections, ensuring key stakeholders are well-prepared and informed.

• Collaborate with SMEs and Business Process Owners (BPOs) to ensure consistent and high-quality responses and support the development and promotion of Global Quality Documentation.

• Supports the preparation, execution and closure of regulatory inspections. Ensures responses are qualitative and submitted on time and resulting CAPA are implemented as committed. Maintain a system ensuring continuous inspection readiness.

• Maintain oversight of Sanofi’s aggregate GMP US FDA findings and action plans, for trending purposes, and ensuring accurate reporting to Operations Management and Global Quality.

·       Core member of critical governance

• Sanofi’s GMP GDP Quality Council to facilitate sharing of US FDA inspection findings and best practices across entities, M&S sites, R&D, and countries

• Quality Audit Inspection Intelligence & Advocacy Leadership Team

• Lead cGMP compliance projects aligned with the company's Quality Operations strategy and US FDA regulations.

• Drive digital transformation initiatives

• Contribute US FDA domain expertise to the development of predictive models for quality risk exposure and risk-based auditing.

• 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.

Management Responsibilities:

This position has no direct reports. This position interacts with:

• Quality Audit Inspection Intelligence & Advocacy Leadership and Department

• Compliance heads, Cluster Quality heads and PQL across all global business units (GBUs) Site Quality Managers

• Operational functions within GBUs

• Global Quality functions including the quality technical experts and quality business process owners (BPOs).

 Latitude of Action:

• This position reports solid line to the Head of Quality Audit Inspection Intelligence & Advocacy. 

• The role holder is required to work autonomously taking decisions in line with Sanofi Global Quality Policy, Standards, Procedures and Processes.

• The role holder is highly independent strategic thinker and has strong compliance mindset; results-driven, can-do-attitude, solution-oriented, change-agent, patient centric mindset, innovative and resourceful.

Role Impact:

• The role provides a key link among all US FDA exposed si