Director Global Quality Sanofi Cambridge

Job description
Position Desription

• Conducts Quality Due Diligences for Global and Regional (multi-country) GMP Commercial and Phase 3 Projects

• Development and Maintenance of Quality Due Diligence related Quality Documents

• Supports all the Group entities in Quality Due Diligence activities



• Actively communicates and supports Business Development and Licensing teams and Operational Quality Units

• Reports KPIs (Quality Due Diligences)

• Leads and conducts Baseline Audits post Due Diligence deal approval

• Conducts Mock PAIs for new products related activities

• Support Global Quality Documents Task Request Commissions

Basic Qualifications

• Bachelor's Degree or equivalent with at least 10 years relevant experience in the Pharmaceutical Industry or a major Regulatory Authority.

Certified auditor with experience in GxP compliance

Preferred Qualifications

• Prefer fluency in English OR French plus Spanish or Portuguese

• People Management experience

• Risk-Controls and Management

• GxP Regulations i.e. ANSM, USFDA, EU, WHO, ICH

• Compliance and Regulatory Inspections

• Continuous Process Improvements Methodology

• Thorough experience in auditing or inspecting regulated healthcare sectors

• Operational Experience in at least one technical field: production or quality or medical affairs or regulatory affairs or Pharmacovigilance or Regulatory Inspections as an Investigator

• Advanced knowledge of regulations applicable to Medicinal and Medical Device products for Human and Animal Use

• In-depth knowledge of Pharmaceutical Operations

• Results-driven, can-do-attitude, solution-oriented, strategic thinker, change-agent, compliance-patient centric mindset, resourceful, innovative

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