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Global Quality Auditor (GxP)
133 500 - 192 833$
Описание вакансии
Текст:
TL;DR
Global Quality Auditor (GxP): Conducting GxP audits and transversal assessments across Sanofi’s global quality organizations, country organizations, and external third parties with an accent on GCP, GVP, risk-based auditing, and quality management systems. Focus on leading audits, evaluating entity risks, managing CAPAs, escalating critical issues, and shaping audit and inspection strategy.
Location: Remote within the US; position listed in Morristown, New Jersey. US and Puerto Rico residents only.
Salary: $133,500–$192,833.33 annually
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.
What you will do
- Lead or support GxP audits covering Good Clinical Practices and Good Pharmacovigilance Practices.
- Conduct transversal assessments and develop targeted, risk-based audit agendas and mitigation recommendations.
- Review and approve audit reports, contribute to team scheduling, and escalate critical issues and risks.
- Approve and manage corrective and preventive actions (CAPAs) and perform due diligence assessments.
- Collaborate with Quality Audit, Inspection, Intelligence & Advocacy teams and external strategic vendors.
- Contribute to quality management system materials, including training curricula, audit agendas, and controlled documents.
Requirements
- BS or BA in Pharmacy, Life Sciences, Engineering, or a related field; other degrees may be considered.
- At least 5 years of extensive experience in GxP, Good Pharmacovigilance Practices, or Good Clinical Practices.
- Deep knowledge of global regulatory requirements and standards.
- Strong understanding of quality management systems and quality risk assessment.
- Ability to lead cross-functional teams, communicate clearly, work independently, and apply a strong compliance mindset.
- Must be eligible for the US-based role; remote work is within the US.
Culture & Benefits
- Supportive, future-focused environment with opportunities for promotion and lateral career moves.
- Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Opportunities to work with digital, data, and AI-driven innovation in medicine and vaccine delivery.
- Employee rewards and benefits tied to demonstrated contribution and impact.