[Urgent Search] Global Quality Lead, GMP, GDP Audit and Inspection – Pipeline Launch Position Available In Morris, New Jersey

Job Description:

Job Title:

Global Quality Lead, GMP, GDP Audit and Inspection•

Pipeline Launch Location:

Framingham, MA or Morristown, NJ Aboutthe Job We deliver 4.3 billion healthcare solutions to people everyyear, thanks to the flawless planning and meticulous eye for detailof our Manufacturing & Supply teams. With your talent and ambition,we can do even more to protect people from infectious diseases andbring hope 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.

Thiscritical role:

• Covers all Lifecycle phases of pre-authorizationto regulatory submission, submission to pre-approval inspection(PAI), PAI to launch, and commercial activities.
• Current GoodManufacturing Practice (cGMP), Good Distribution Practice (GDP).
• Supports Sanofi’s Diverse product portfolio across all GBUs;Specialty Care, Vaccines, General Medicines. Internal and ExternalAuditing and Regulatory Inspections.
• Covers an internationalscope including major regulators; US FDA (USA), EMA (Europe), ANSM(France), National Medical Products Administration (China), PMDA(Japan), ANVISA (Brazil).

We are an innovative global healthcarecompany with one purpose: to chase the miracles of science toimprove people’s lives. We’re also a company where you can flourishand grow your career, with countless opportunities to explore, makeconnections with people, and stretch the limits of what you thoughtwas possible. Ready to get started?

Main Responsibilities:

• Actsas a lead auditor or co-auditor, in accordance with Sanofiprocesses.
• Facilitates qualification of new auditors, trains andcoaches other auditors to share knowledge and facilitatedevelopment.
• Conducts transversal assessments.
• Prepares,coaches, and supports entities for Regulatory Inspections throughvarying methods such as Mock Inspections, unannounced orshort-notice visits, etc.
• Participates in External Associationsto stay current with emerging trends.
• Contributes to teamscheduling and reviews/approves audit reports for team members.
• Evaluates entity risks developing targeted risk-based agendasand/or advise on mitigations.
• Escalates critical issues andrisks.
• Approves/manages CAPAs.
• Participates in QualityGovernance Committees (e.g., Pre-Approval Management Group,Inspection RISk and Compliance Council (IRISC), etc) as/whenneeded.
• Performs due diligence assessments, as/when needed.
• Participates in audits and activities with other teams in SanofiQuality Audit, Inspection, Intelligence & Advocacy.
• Collaborateswithin Quality Audit, Inspection, Intelligence & Advocacydepartment team members for Insight Generation.
• Contributes tothe creation of departmental QMS such as Training Curriculum,standard audit agendas, and controlled documents.

• Management:

  Nodirect reports. May lead cross-functional teams for initiatives orprojects. Serves as Deputy of Head of GMP/GDP Audit, Inspection

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

•

Roleimpact:

Able to detect evolving trends which will result inadjustment of Sanofi audit and inspection strategy and tactics.

Plays a key role in transforming the practice of auditing inSanofi.

• Scope:

  Manufacturing & Supply, Research & Development,Countries, Digital, Global Quality organizations in Sanofi. Andthird parties outside of Sanofi (e.g., Alliance Partners, CMOs,Strategic Vendors, etc.) About You Experience, Education, SoftSkills, Technical Skills, Languages Basic Qualifications

• Minimumbachelor’s degree in science, pharmacy, engineering, data science,or equivalent with at least 10 years relevant experience in thepharmaceutical, biotech, medical device or a related industry or ata Regulatory agency with a focus on pharma/biotech.
• At least fiveyears relevant experience as Quality Auditor.
• Direct experiencepreparing for and supporting Regulatory Inspections from Regulators(e.g., US FDA, ANSM, PMDA, NMPA, EMA, MHRA, etc.)
• Actionoriented, results driven, performance and patient focused mindset
• Familiar with Data Integrity, Data Privacy, and Cybersecurityrequirements across GXPs.
• Ability to interpret complex data,identify key trends, and draw meaningful conclusions.
• Robustknowledge of current international regulations relevant to scope ofauditing, inspection domain, including practical application in acomplex regulatory environment.
• Previous experience withinternational business travel of ~50%.
• Excellent written andverbal communication skills to effectively present findings todiverse audiences.
• Fluent English. Preferred Qualifications
• Advanced degree (Masters or Doctorate) in science, pharmacy,engineering, data science, or equivalent
• Experience preparing forand direct support of

US FDA GMP

Pre-Approval Inspections, andfollow up activities (e.g., inspection response process, completeresponse letters (CRLs), post-application action letters (PAAL),information requests (IRs), etc.)

• Experience in domain that isbeing audited areas, with deep knowledge in one or two domains(e.g., Operational experience in Clinical, Pharmacovigilance,Manufacturing, Site Quality Head for a Manufacturing Site, etc.).
• Previous experience as a Regulatory Authority Inspector.
• Memberof International Society for Pharmaceutical Engineering (ISPE),BioPhorum, BSI, and/or Parenteral Drug Association (PDA) withworking group experience.
• French speaking and/or other languagesis a plus. 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’gender-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-Onsite 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.