Vaccines - Head of Global Audit M/F

Recruiter
Sanofi
Location
Lyon, France
Salary
Competitive salary
Posted
17 May 2021
Closes
26 May 2021
Ref
R2580602
Experience level
Director
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 Head of Global Audit.

The mission will consist of monitoring complex set of inputs including current environment, industry trends and emerging regulations in order to anticipate potential risks and the need for changes and influence site and global management directions regarding new or revised strategic initiatives, and analyzing results of quality system assessments conducted within the network and align strategic improvements with site and global stakeholders.

Key Accountabilities

  • Proposes global KPIs, communicates to the Site/Function Leadership Team, Trends and develops remediation plan in alignment with key stakeholders
  • Performs strategic or high-profile global self-inspections
  • Advises sites or functions on inspection readiness or post inspections responses
  • Coaches those developing and implementing self-inspection audit systems across the network
  • Analyses self-inspection outcomes across the network and proposes and aligns improvement strategies with SP leadership
  • Develops and maintain SP self-inspection framework and strategy on self-inspection audits
  • Identifies innovative approaches to self-inspection audit capability within the network (e.g., benchmark) and implements improvement ideas


Scope and Dimensions

Key indicators on which the job holder will be evaluated :
  • Performs strategic or high-profile global self-inspections
  • Performs reviews and assessments of data in order to identify potential issues, risks as well as improvement actions
  • Analyzes and interprets the site or global self-inspection KPIs and associated trends and proposes improvement actions within the network
  • Proposes global KPIs, communicates to the Site/Function leadership team, trends and develops remediation plan in alignment with key stakeholders across the network
  • Identifies innovative approaches to self-inspection audit capability within the network (e.g., benchmark) and implements improvement ideas
  • Develops and maintain SP self-inspection framework and strategy on self-inspection audits


Education and Experience

Bachelor of Science in a scientific field:
  • At least 10 years self-inspection audit
  • Proven experience in leading complex or key self-inspection audits
  • Proven experience with developing and deploying self-inspection audit strategies designed to identify areas of higher risk and experience with implementation of continuous improvement initiatives
  • Able to effectively communicate to senior management in writing and verbally in English (additional languages are a 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.