Sanofi
Sanofi
Sanofi ir globāls veselības aprūpes un farmācijas uzņēmums, kas izstrādā zāles, vakcīnas un patērētāju veselības produktus. Tā pētniecība aptver imunoloģiju, neiroloģiju, onkoloģiju, retās slimības un citas jomas, kurās zinātnes sasniegumi var palīdzēt risināt būtiskas veselības vajadzības. Uzņēmums darbojas arī alerģijas, klepus, saaukstēšanās un gripas produktu, kā arī plašāku fiziskās un garīgās labsajūtas produktu jomā, savā pētniecības un izstrādes darbā daļēji izmantojot mākslīgo intelektu. Sanofi apvieno zinātnisko, ražošanas un veselības aprūpes kompetenci, lai veicinātu ārstēšanas iespējas un atbalstītu sadarbību, kuras mērķis ir uzlabot neaizsargātu kopienu piekļuvi ārstēšanai un veselības rezultātus visā pasaulē.

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.

Apraksts

  • 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

Prasības

  • 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

Priekšrocības

  • 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

Saistītās vakances

Ecommpay

Junior to Mid-Level Analytics Engineer, Europe (Hybrid)

Ecommpay

Build dependable SQL, Python, and Looker data foundations for Ecommpay’s global payments business. Support consistent business metrics and internal AI applications.

Atvērt
R-Zero

Staff Analytics Engineer, Building Energy Systems

R-Zero

Staff Analytics Engineer validating building performance findings, energy savings, and HVAC controls for R-Zero’s smart-building platform. Develops measurement and verification methods and BACnet-based automation for commercial buildings.

Atvērt