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Country Quality Head and RP-i – Consumer Healthcare

Posted 26 Jan 2024
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Work experience
2 to 3 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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  • Location : Reading, United Kingdom

  • Remote Working : 50%

  • Job type: Permanent,Full time

About the job

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.

In order to do so, 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.

Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.

Main responsibilities of the role:

Reporting to the CHC Zone Quality Head Western Europe, Italy & Germany, the Country Quality Head / GDP Responsible Person – CHC will lead and manage the implementation and maintenance of the CHC UK 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.

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

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

  • Implementing and maintaining training programs.

  • Coordinating promptly recall operations for various products.

  • Handling customer complaints effectively.

  • Approving suppliers, customers, and subcontracted activities impacting GDP.

  • Conducting regular self-inspections and implementing corrective measures.

  • Managing records of delegated duties.

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

  • Ensuring adherence to national law requirements.

  • Responsible (as RP-I), for implementing a system to confirm that for UK licensed products that have been imported into Great Britain from countries on an approved country for import list, that the required QP certification has taken place.

  • Responsible for ensuring the effectiveness of these certification checks.

Scope and Role Impact:

  • Cross-functional management within the CHC UK Affiliate.

  • Key role in ensuring consistent application of Quality requirements.

  • Management of a Country Quality Associate

About you

Mandatory requirement : For RP-I role, you must be a full member of a professional body with a published code of conduct. Acceptable professional body memberships are:

  • Royal Society of Biology

  • Royal Pharmaceutical Society

  • Pharmaceutical Society of Northern Ireland

  • Royal Society of Chemistry

  • Educational Qualifications: Candidates must possess a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology, or a related life science.

  • Experience: Experience in Quality Systems, Continuous Improvement, and Life-cycle Management. Candidates should have significant experience in the Good Distribution Practice (GDP) domain within an affiliate setting and you must be able to demonstrate, that you have a minimum of 2 years’ experience in performing the functions of a responsible person on a WDA(H).

  • Knowledge:

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

    • Familiarity with EU Good Distribution Practices.

  • Languages: Proficiency in English

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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

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 videoand check out our Diversity Equity and Inclusion actions at sanofi.com!

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.

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions.

Pharmaceutical
Amsterdam
100,000 employees