Sanofi
Sanofi
Sanofi este o companie globală din domeniul sănătății și al produselor farmaceutice, care dezvoltă medicamente, vaccinuri și produse de sănătate pentru consumatori. Cercetarea sa acoperă imunologia, neurologia, oncologia, bolile rare și alte domenii în care progresul științific poate răspunde unor nevoi importante de sănătate. Compania lucrează, de asemenea, la produse pentru alergii, tuse, răceală și gripă, precum și la produse pentru o stare generală mai bună de sănătate fizică și mintală, folosind inteligența artificială în anumite etape ale activității de cercetare și dezvoltare. Sanofi reunește expertiză științifică, de producție și de asistență medicală pentru a avansa tratamentele și pentru a susține colaborări menite să îmbunătățească accesul și rezultatele pentru comunitățile vulnerabile din întreaga lume.

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.

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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