? [Urgent Search] Compliance Head, U.S. FDA Position Available In Middlesex, Massachusetts

Job Description:

Job Title:

Compliance Head, U.S.

FDA Location:

Framingham, MA(Primary); Morristown, NJ, Swiftwater, PA About the Job We deliver4.3 billion healthcare solutions to people every year, thanks tothe flawless planning and meticulous eye for detail of ourManufacturing & Supply teams. With your talent and ambition, we cando even more to protect people from infectious diseases and bringhope to patients and their families. Foster best-in-classperformance by leveraging data, technology and diverse talents tosecure product launches and support compliance through audits,inspections, regulatory surveillance, and advocacy. Grounded incore values Integrity, Collaboration, Innovation, Expertise. We arean innovative global healthcare company with one purpose: to chasethe miracles of science to improve people’s lives. We’re also acompany where you can flourish and grow your career, with countlessopportunities to explore, make connections with people, and stretchthe 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 exposedsites within Sanofi and the external network (e.g., CMOs, AlliancePartners, etc.):

• Enhance inspection readiness through on-sitequality system assessments, audits, identifying gaps, anddeveloping mitigation action plans.
• Oversee FDA inspectionpreparation, providing guidance, training, and coaching to ensurethorough readiness and effective response management.
• Providedirect support to

US FDA GMP

inspections on-site to ensuresuccessful outcomes.

• In collaboration with the sites, coordinateand prepare briefing materials for US FDA inspections, ensuring keystakeholders are well-prepared and informed.
• Collaborate withSMEs and Business Process Owners (BPOs) to ensure consistent andhigh-quality responses and support the development and promotion ofGlobal Quality Documentation.
• Supports the preparation, executionand closure of regulatory inspections. Ensures responses arequalitative and submitted on time and resulting CAPA areimplemented as committed. Maintain a system ensuring continuousinspection readiness.
• Maintain oversight of Sanofi’s aggregate

GMP US FDA

findings and action plans, for trending purposes, andensuring accurate reporting to Operations Management and GlobalQuality.

• Core member of critical governance
• Sanofi’s GMP GDPQuality Council to facilitate sharing of US FDA inspection findingsand best practices across entities, M&S sites, R D, andcountries
• Quality Audit Inspection Intelligence & AdvocacyLeadership Team
• Lead cGMP compliance projects aligned with thecompany’s Quality Operations strategy and US FDA regulations.
• Drive digital transformation initiatives
• Contribute US FDA domainexpertise to the development of predictive models for quality riskexposure and risk-based auditing.
• Represent Sanofi externally atkey industrial and trade association meetings and in workinggroups.
• Foster a culture of quality and cGMP compliance, engagingall organizational levels to drive continuous improvement.

Management Responsibilities:

This position has no direct reports.

This position interacts with:

• Quality Audit InspectionIntelligence & Advocacy Leadership and Department
• Complianceheads, Cluster Quality heads and PQL across all global businessunits (GBUs) Site Quality Managers
• Operational functions withinGBUs
• Global Quality functions including the quality technicalexperts and quality business process owners (BPOs).

Latitude ofAction:

• This position reports solid line to the Head of QualityAudit Inspection Intelligence & Advocacy.
• The role holder isrequired to work autonomously taking decisions in line with SanofiGlobal Quality Policy, Standards, Procedures and Processes.
• Therole holder is highly independent strategic thinker and has strongcompliance mindset; results-driven, can-do-attitude,solution-oriented, change-agent, patient centric mindset,innovative and resourceful.

Role Impact:

• The role provides a keylink among all US FDA exposed sites and entities in the GMPnetwork.
• It is a key role in ensuring coherent development androll-out of the Sanofi Quality Management System in line with USFDA cGMP regulatory requirements, Pharmaceutical Quality System ICHQ10 and Sanofi quality policy across the managed manufacturingsites’ network. About You Basic Qualifications
• A minimum of aMaster’s degree in science, pharmacy, engineering, data science, orequivalent is required
• Current or recent employment at US FDA(within last 3 years) and US FDA experience (>10 years) with aminimum of 15 years relevant experience in the pharmaceutical,biotech, medical device, or related industries.
• Extensiveknowledge of Quality Systems and Data Integrity is required.
• Strong command of manufacturing processes, validation principles,risk assessment methodologies, and statistical techniques.
• Aminimum of eight or years of professional experience as an auditorand/or inspector is required.
• Previous experience interfacingwith Regulatory Authority Inspectors from different regions of theworld.
• Inclusive, transformational, pragmatic leadership, changemanagement
• Fluency in French speaking is a plus.
• This positionmay require up to 50% overall business travel PreferredQualifications
• Member of International Society for PharmaceuticalEngineering (ISPE), BioPhorum, BSI, and/or Parenteral DrugAssociation (PDA) with working group experience in authoringguidance documents and/or white papers.
• French speaking is aplus. Why Choose Us?
• Bring the miracles of science to lifealongside a supportive, future-focused team.
• Discover endlessopportunities to grow your talent and drive your career, whetherit’s through a promotion or lateral move, at home orinternationally.
• Enjoy a thoughtful, well-crafted rewards packagethat recognizes your contribution and amplifies your impact.
• Takegood care of yourself and your family, with a wide range of healthand wellbeing benefits including high-quality healthcare,prevention and wellness programs and at least 14 weeks ofgender-neutral parental leave.

Sanofi Inc. and its U.S. affiliatesare Equal Opportunity and Affirmative Action employers committed toa culturally diverse workforce. All qualified applicants willreceive 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 militarystatus; domestic violence victim status; atypical cellular or bloodtrait; genetic information (including the refusal to submit togenetic testing) or any other characteristic protected by law.

GD-SG LI-GZ

LI-Hybrid vhd All compensation will be determinedcommensurate with demonstrated experience. Employees may beeligible to participate in Company employee benefit programs, andadditional benefits information can be found here.