Global Head of Audits and Inspections, Consumer Healthcare

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 coordinates its implementation across the group. This role provides 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. The individual will create, design, and lead the strategy of inspection preparation and management and support to sites and all CHC entities, ensuring GXP compliance of the CHC entity.

Main responsibilities :

1. Leadership of the CHC Global Quality Audit team encompassing all activities.
2. Creation and leadership of a system for auditing internally, externally, and managing inspection readiness.
3. Provides leadership on key activities related to audits of CHC sites / locations and key third parties.
4. 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.
5. Provides direction and support for the team for CHC site regulatory inspections.
6. 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).
7. Interacts with Internal Audit and Internal Control to identify and implement audit approaches that benefit CHC.
8. Creates CHC Global Quality Directives, Standards, Guidelines, and Procedures.
9. 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 :

1. All CHC and key third-party Quality & GxP activities.
2. Regulatory inspections and liaison with authorities.
3. Preparation and inspection readiness activities
4. Manufacturing and development in pharmaceutical, biotechnologies, sterile products, API, devices, nutraceuticals, consumer healthcare, medical devices, food supplements.
5. Clinical, medical, pharmacovigilance, regulatory Computerized systems.
6. Project Management.
7. Financials and budgeting.

Key Contributions & Activities

Head of all Global Auditing and Inspection activities. Design and creation of Audit approach and system. This role is strategic in audit and inspection readiness and in identifying and managing risk related to compliance and quality GXP requirements. It directly surveils our right to manufacture and sell our products and serves as 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 is an advantage. Significant international exposure and exposure to key Health Authorities.

Technical skills :

• Qualified Auditor.
• 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.

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.