• Location: Paris
• Job type: Permanent, Full time

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.  

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.  This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. 

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. 

Join us on our mission. Health. In your hands. 

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

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!#LI-ONSITE#LI-HYBRID#LI-CHC