Global CHC Quality – Global Head Audits and Inspections – Sanofi - Paris.
About the job
Our Team:
The Global Head of Audits and Inspections creates, defines, and leads the CHC (Consumer HealthCare) Global Quality Audit policy and to coordinate its implementation across the group and to provide an accurate, independent assessment of internal M&S / R&D sites, country offices, CDMOs and Suppliers, for compliance with CHC Quality Policy / requirements and applicable regulations through audit and inspection support activities. To create, design and lead the strategy of inspection preparation and management and support to sites, and all CHC entities. Ensures the GXP compliance of the CHC entity.
Main responsibilities:
Leadership of the CHC Global Quality Audit team encompassing all activities.
Creation and leadership of system of auditing internally, externally and Inspection readiness and management
Provides leadership on key activities related to audits of CHC sites/locations and key third parties.
Creates, directs leads and approves the annual audit plan, associated planning and management reporting of activities and audit outcomes for all relevant entities internal and external.
Provides direction and support for the team for CHC site regulatory inspections.
Ensures close interaction with the CHC Chief Quality Officer and Global Quality Senior Leadership team to ensure good governance of the activities, audit findings and related CAPA (Corrective and Preventive Actions).
Interacts with Internal Audit and Internal Control to identify and implement audit approaches that benefits to CHC.
Creates CHC Global Quality Directives, Standards, Guidelines and Procedures.
Engages with Regulatory authorities and external industry organizations to create leadership and collaboration opportunities for CHC through interaction with other companies and regulators related to pharmaceutical/biopharmaceutical manufacturing science and regulation.
Potential Specific Domains
The following areas are of responsibility and expertise:
All CHC and key third-party Quality & GxP activities.
Regulatory inspections and liaison with authorities
Preparation and inspection readiness activities
Manufacturing and development in pharmaceutical, biotechnologies, sterile products, API, devices, nutraceuticals, consumer healthcare, medical devices, food supplements
Clinical, medical, pharmacovigilance, regulatory Computerized systems
Project Management
Financials and budgeting
Key Contributions & Activities
Head of all Global Auditing and Inspection activities. Design and creation of Audit approach and system.
The role is a strategic role in audit and inspection readiness and to identify and manage risk related to compliance and quality GXP requirements. It is directly surveilling our right to manufacture and sell our products. It is a key link to Operational Quality Units (Manufacturing sites, Distribution centers, EM and Country Quality and EM Quality Units) and Global Quality CHC team and CHC Chief Quality Officer
About you
Experience: Minimum 15 Years experience in Quality management and pharmaceutical production with a good mix of technical, leadership and operational experience. Qualified Person status and advantage. Significant international exposure and exposure to key Health Authorities.
Technical skills:
Qualified Auditor
Continuous improvement
GxP and health-related regulations
Quality risk analysis
Quality risk management
Quality systems
Regulatory and company requirements, specifically pharmaceutical drug and nutraceuticals
Regulations, e.g., drug law, GMP, Pharmacopeia, ICH
Soft skills: Organization and communication skills, networking capability, leadership, and assertiveness skills.
Education: Minimum Bachelors degree in Pharmacy, Chemistry or related discipline. Masters/ PhD preferred
Languages: English / French
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our and check out our Diversity Equity and Inclusion actions at
#Sanofi #WeNeverSettle
#SanofiCareers
#PursueProgress
#DiscoverExtraordinary
#joinsanofi
#careerswithpurpose
#LI-EUR
#LI-CHC
Pursue , discover
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our and check out our Diversity Equity and Inclusion actions at !
