CHC Global Head of Audits and Inspections

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

Opella, is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.
At the core of this mission is our 100+ loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers.
Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission to bring health in your hands at www.opella.com.

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 s