Sanofi
Sanofi
Sanofi yra pasaulinė sveikatos priežiūros ir farmacijos įmonė, kurianti vaistus, vakcinas ir vartotojų sveikatos priežiūros produktus. Jos moksliniai tyrimai apima imunologiją, neurologiją, onkologiją, retąsias ligas ir kitas sritis, kuriose mokslo pažanga gali padėti spręsti svarbius sveikatos poreikius. Įmonė taip pat kuria alergijos, kosulio, peršalimo ir gripo produktus bei platesnius fizinę ir psichinę gerovę palaikančius produktus, o dalyje mokslinių tyrimų ir plėtros darbų taiko dirbtinį intelektą. Sanofi telkia mokslinę, gamybinę ir sveikatos priežiūros kompetenciją, kad skatintų gydymo pažangą ir remtų bendradarbiavimą, kuriuo siekiama gerinti pažeidžiamų bendruomenių galimybes gauti gydymą ir gydymo rezultatus visame pasaulyje.

Global GxP Quality Auditor – Sanofi, United States Remote

Lead global GxP audits across Good Clinical Practice and Good Pharmacovigilance Practice for Sanofi’s biopharmaceutical operations. Assess quality risks, oversee CAPAs, and help advance worldwide audit strategy.

Aprašymas

  • Lead GxP audits covering Good Clinical Practice and Good Pharmacovigilance Practice
  • Serve as lead or supporting auditor under Sanofi procedures
  • Complete cross-functional and transversal quality assessments
  • Help schedule audits and review or approve colleagues’ audit reports
  • Assess entity-level risks, create risk-based agendas, and recommend mitigations
  • Escalate significant quality issues and risks
  • Approve and oversee corrective and preventive actions
  • Carry out due diligence reviews when required
  • Collaborate with Sanofi Quality Audit, Inspection, Intelligence, and Advocacy teams on audits and related work
  • Develop departmental QMS resources, including training curricula, standard agendas, and controlled documents
  • Monitor emerging trends to shape audit and inspection strategies and tactics
  • Support the modernization of auditing practices across Sanofi’s global quality organizations, country teams, and third parties

Reikalavimai

  • Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or a related field; other degrees may also be considered
  • At least five years of substantial experience in GxP, Good Pharmacovigilance Practice, or Good Clinical Practice environments
  • In-depth knowledge of global regulatory requirements and standards
  • Strong understanding of quality management systems
  • Capability to lead cross-functional teams and initiatives
  • Proven expertise in assessing and reducing quality risks
  • Excellent written and verbal communication skills
  • Strong independence and creative problem-solving skills
  • High ethical standards and a considered approach to risk-taking
  • Ability to identify emerging trends and adapt strategies accordingly
  • Applicants must reside in the United States or Puerto Rico

Privalumai

  • Promotion and lateral-mobility opportunities in domestic and international roles
  • A rewards package aligned with individual contributions
  • Comprehensive healthcare coverage
  • Prevention and wellness initiatives
  • At least 14 weeks of gender-neutral parental leave
  • Access to advanced technology and a digitally enabled environment focused on data and AI innovation

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