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Audit & Inspection Readiness Manager

Sanofi U.S.

People at Sanofi are dedicated to making a difference in patients’ daily lives, enabling them to enjoy a healthier life.

REPORTING TO THE AUDIT AND INSPECTION READINESS HEAD, THE INCUMBENT IS RESPONSIBLE TO ENSURE:

  • Participation in the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (GPV) and country PV offices in anticipation of regulatory inspections and audits.
  • Active involvement in the preparation, conduct, and follow-up of GxP regulatory inspections impacting PV until closure.
  • Active involvement in the organization of appropriate support for the preparation, conduct, and follow-up of Global Quality audits impacting country GxP activities, global PV processes/tools or Business Partner audits, until closure.
  • Follow-up of audit/inspections of PV-related Corrective and Preventive Actions (CAPAs) to ensure timely completion and coordination of CAPA effectiveness reviews in collaboration with CAPA owners, as needed to prevent a recurrence.
  • Management of Business Partners and Global Service Providers PV Audits activity, in collaboration with external auditors and related GPV functions.
  • PV Quality Liaison role for Country Safety Heads / Multi-Country Safety Heads for an assigned group of countries by providing Quality oversight across countries on the country PV deliverables and highlighting PV Quality risks, issues and mitigation plan(s) to the Regional PV / Quality Heads.
  • Support in external relations with Inspectorates / Agencies / Pharma associations / Inter-Company network to ensure surveillance of PV inspections regulations/practices and benchmark on recurrent PV findings.

EDUCATION AND EXPERIENCE

  • Bachelor’s or higher in Pharmacy (BS, RPh, Pharm D) or Bachelor’s or higher in nursing (BSN, BScN) or biological science discipline (Biology, Health Sciences…).
  • A minimum of 5 years of experience in Pharmacovigilance or clinical field, preferably in quality management activities.
  • A minimum of 7 years of experience in the global pharmaceutical industry, including experience in both post-marketing and clinical development activities.
  • Experience working in a global environment, across diverse cultures.

PROFILE

  • Capability to work under extreme pressure.
  • Excellent communication skills (oral and written).
  • Excellent organizational and planning capabilities.
  • Ability to work in transversal/cross-functional teams.
  • Excellent teamwork and interpersonal skills.
  • Ability to take initiative and overcome challenges.
  • Ability to interact with inspectorates from Health Authorities in a constructive manner.
  • Excellent knowledge of International (ICH/CIOMS), EU (Good PV practices), and FDA regulations in the domain of Pharmacovigilance.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

#LI-GZ

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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Audit & Inspection Readiness Manager

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Sanofi U.S.

People at Sanofi are dedicated to making a difference in patients’ daily lives, enabling them to enjoy a healthier life.

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