CHC Country Quality Head

Job description

About the job

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.

Our Team:

CHC Quality EUROPE & LATIN AMERICA (EULA) – QUALITY CEE

We make sure that safe and reliable Health Care goods (CHC Drug & Non-Drug (e.g. Cosmetics, Food Supplements, Medical Devices, …) “Love Brands”) are manufactured, distributed and available in Europe and LatAm countries (EULA region) to meet the healthcare needs and expectations and to satisfy our consumers and patients. We are a diverse, gender-balanced Team, with a strong customers-focus, all very engaged, permanently in the move with agility.

We support business priorities by ensuring Quality of CHC products, information and services to ensure patients/customers safety, thus contributing to “Take Health in your Hands”.

The position of Country Quality Head / GDP Responsible Person – CHC will lead and manage the implementation and maintenance of the CHC Romanian Affiliate Quality System, ensuring compliance with GxP regulatory requirements, Global Quality standards, and national EU legislation.

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

Main responsibilities:

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Implementing and maintaining a quality management system for various health-regulated products.

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Managing authorized activities, ensuring accuracy and quality of records.

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Implementing and maintaining training programs.

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Coordinating recall operations for various products.

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Handling customer complaints effectively.

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Approving suppliers, customers, and subcontracted activities impacting GDP.

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Conducting regular self-inspections and implementing corrective measures.

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Managing records of delegated duties.

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Deciding on the disposition of returned or recalled products.

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Ensuring adherence to national law requirements.

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Overseeing the management and documentation of the QMS pertaining Medical Devices

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Scope and Role Impact:

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Cross-functional management within the CHC Romanian Affiliate.

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Key role in ensuring consistent application of Quality requirements.

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Management of a Country Quality Manager/ Responsible Person Deputy

About you

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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.

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Soft skills: Strong leadership, communication, negotiation, and problem-solving skills. Ability to act for change, commit to customers, and lead teams strategically

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Technical skills: Advanced understanding of GxP, Quality risk analysis and management, Regulatory requirements. Familiarity with EU Good Distribution Practices. Experience in Quality Systems, Continuous Improvement, and Life-cycle Management

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Education: Candidates must possess one of the following degrees, obtained in accordance with legislation, and the following experience:

- Legal diploma of pharmacist or physician

- Active membership with validity for the current year in the Pharmacists’/Physicians’ National Association

- At least 1 year experience in a similar position

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Languages: Fluent in English

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.