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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 sites and entities in the GMP network.

• It is a key role in ensuring coherent development and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi quality policy across the managed manufacturing sites’ network.

About You

Basic Qualifications

• Minimum of a Bachelors Degree is required. Master’s degree in science, pharmacy, engineering, data science, or equivalent is preferred.

• Current or recent employment at US FDA (within last 3 years) and US FDA experience (>10 years) with a minimum of 15 years relevant experience in the pharmaceutical, biotech, medical device, or related industries. 

• Extensive knowledge of Quality Systems and Data Integrity is required.

• Strong command of manufacturing processes, validation principles, risk assessment methodologies, and statistical techniques. 

• A minimum of eight or years of professional experience as an auditor and/or inspector is required.

• Previous experience interfacing with Regulatory Authority Inspectors from different regions of the world.

• Inclusive, transformational, pragmatic leadership, change management.

• This position may require up to 50% overall business travel

Preferred Qualifications

·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 of 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.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.