Country Quality Manager France - all genders

Job Requisition: Country Quality Manager for Consumer Healthcare (CHC) - France

Reports to: CHC Country Quality Head France

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Mission and Key Responsibilities:

Our team: The Country Quality Manager will lead and manage the implementation and maintenance of the CHC French Affiliate Quality System, ensuring compliance with GxP regulatory requirements, Global Quality standards, and national and EU legislation.

This role includes overseeing Good Distribution Practice of medicinal products for human use, Medical Devices and food supplements regulations.

Key responsibilities include:

• Implementing and maintaining a quality management system for various health-regulated products including Country quality documentation management system, management of deviations, CAPAs and Change Controls

• Implementing and maintaining an annual training program.

• Conducting regular self-inspections and implementing corrective measures.

• Organizing and contributing to the Country Quality Review with the internal functions involved.

• Monitoring and reporting on the Country KPIs defined.

• Monitoring of locally managed subcontractors for all GxP and regulated activities.

• Managing of quality risks

• Managing authorized activities, ensuring accuracy and quality of records.

• Handling customer and quality complaints effectively.

• Coordinating recall operations for various products.

• Check the conformity and approve customers.

• Managing records of delegated duties.

• Ensuring the timely completion of Product Quality Review (PQRs)

• Deciding on the final disposition of returned, rejected, recalled, or potentially falsified products.

• Monitoring of product stocks and reporting any supply tensions or shortage to Healthcare Authorities.

• Ensuring coordination of activities related to the promotional information charter (annual certification audit, specific management review, steering committee, working groups).

• Ensuring adherence to national law requirements.

Scope and Role Impact:

• Cross-functional management within the CHC France Affiliate.

• Key role in ensuring consistent application of Quality requirements.

Required Skills and Experience:

• Educational Qualifications: Candidates must hold a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy.

• Experience: Candidates should have significant experience in the Good Distribution Practice (GDP) domain within an affiliate setting, demonstrating a thorough understanding of the specific challenges and requirements of this area.

• Knowledge:

  • Advanced understanding of GxP, Quality risk analysis and management, Regulatory requirements.

  • Familiarity with EU Good Distribution Practices.

• Languages: Proficiency in English

• Technical/Professional:Experience in Quality Systems, Continuous Improvement, and Life-cycle Management. Veeva Quality knowledge will be considered as a plus.

• Soft Skills:

  • Strong leadership, communication, negotiation, and problem-solving skills.

  • Ability to act for change, commit to customers.