Sanofi
Sanofi
Sanofi एक वैश्विक स्वास्थ्य सेवा और फार्मास्युटिकल कंपनी है, जो दवाइयाँ, टीके और उपभोक्ता स्वास्थ्य उत्पाद विकसित करती है। इसका अनुसंधान इम्यूनोलॉजी, न्यूरोलॉजी, ऑन्कोलॉजी, दुर्लभ रोगों और अन्य क्षेत्रों तक फैला है, जहाँ वैज्ञानिक प्रगति महत्वपूर्ण स्वास्थ्य आवश्यकताओं को पूरा कर सकती है। कंपनी एलर्जी, खाँसी, जुकाम, फ्लू तथा व्यापक शारीरिक और मानसिक स्वास्थ्य से जुड़े उत्पादों पर भी काम करती है और अपने अनुसंधान एवं विकास कार्य के कुछ हिस्सों में कृत्रिम बुद्धिमत्ता का उपयोग करती है। Sanofi वैज्ञानिक, विनिर्माण और स्वास्थ्य सेवा विशेषज्ञता को एक साथ लाकर उपचारों को आगे बढ़ाती है तथा दुनिया भर के संवेदनशील समुदायों की पहुँच और स्वास्थ्य परिणामों में सुधार के उद्देश्य से सहयोग को समर्थन देती है।

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.

विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • 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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