Vaccines - Global Audit Manager M/F

Recruiter
Sanofi Global (French)
Location
Lyon, France
Salary
Competitive salary
Posted
17 May 2021
Closes
22 May 2021
Ref
R2580598
Job role
Audit
Experience level
Manager
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

Mission

The Global Quality Department of Sanofi Pasteur, our Vaccines division is currently building a brand new Quality Inspection & Continuous Improvement team and is looking to integrate his/her future Global Audit Manager.

The mission will consist of identifying key, significant and transversal topics that have the potential to impact on either Sanofi Pasteur's reputation, customers or manufacturing licenses and conducting assessments of the associated quality systems in order to ascertain their compliance status, quality system effectiveness and other areas needing improvement.

In a continuous support mode, aligning improvements with site and global stakeholders and monitor implementation.

Key Accountabilities

  • Leads global self-inspections or reviews reports from these audits, if not the lead
  • Develops audit tools to enhance or improve self-inspection processes and ensures consistent application within the network
  • Works with the Community of Practice to identify areas needing improvement and to monitor implementation
  • Coaches other auditors in auditing techniques and essentials
  • Prepares the site or global Self-inspection audit universe (plan) using risk-based tools
  • Analyzes feedbacks and interprets the site or global self-inspection findings and associated trends and proposes improvement actions
  • Performs reviews and assessments of data in order to identify potential issues, risks as well as improvement actions


Education and Experience

  • Bachelor of Science in a scientific field
  • At least 7 years self-inspection audit or related senior level management experience
  • Proven experience in leading complex or key self-inspection audits or equivalent
  • Proven experience in managing pharmaceutical quality systems using risk management principles
  • Able to effectively communicate to all stakeholders fluently in English (additional languages like French are a very appreciated plus


Business Skills:

  • Consistently uses relevant questioning methods during self-inspection audits to ensure efficient gathering of information in order to identify significant process, system or customer impact
  • Ability to probe and identify issues and their causes and to build trust with the auditee onsite and network stakeholders
  • Ability to communicate and influence senior management
  • Ability to transversally coordinate a team of auditors and develop an overall risk conclusion


Technical and GMP Skills:

  • Proven experience in managing pharmaceutical quality systems using risk management principles
  • Able to apply the changing local and international GMP requirements (e.g., EU, US, WHO, etc.)
  • Uses broad technical expertise in multiple areas (e.g., sterility assurance, contamination controls, quality control & testing, validation & qualification, facility/utility) to propose improvement initiatives
  • Able to effectively apply technical and quality systems expertise to identify issues and system failures


#LI-FR

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.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.