Directeur Qualité Site - Saint-Amand-les-Eaux, France - 541 GlaxoSmithKline Biologicals S.A.S.

Description

"French version, an English version can be found after the French one

Directeur Qualité Site (H/F)

Finalité de l'emploi :

Dans le cadre du respect du Code de la Santé Publique (article R , des Bonnes Pratiques de Fabrication (BPF Europe et GMP en vigueur), et des réglementations pharmaceutiques applicables au site, ainsi que du Code du Travail et des normes du Groupe ,

le Directeur Qualité Opérationnelle aura pour missions principales :

Responsabilités :

Responsabilités EHS :

Qualité :

Coûts :

Délais :

Activités spécifiques :

Le Directeur Qualité Site/qualité opérationnelle :

Profil requis :

Formation et Expérience :

Compétences et Connaissances :

Autres compétences requises :

Pour Postuler :

Si ce poste vous intéresse et que vous correspondez au profil recherché, n'hésitez pas à postuler et à joindre votre CV en anglais ainsi qu'une lettre de motivation détaillant votre expérience et vos compétences pour ce poste.

English version :

Quality Site Head

Purpose of the Job:

In accordance with the Public Health Code (article R , Good Manufacturing Practices (EU GMP and current GMP), pharmaceutical regulations applicable to the site, as well as the Labor Code and Group standards, the Operational Quality Director will have the following main missions:

• Define and implement the site's quality strategy.

• Ensure responsibility for the Quality Assurance (QA)/Quality Control (QC) group: operational QA, system QA, QC.

• Participate as a member of the Management Committee in the site's results responsibility.

Responsibilities:

EHS Responsibilities:

• Ensure the execution of all Quality Assurance (QA)/QC group activities, integrating Environmental Health and Safety (EHS) standards.

• Develop and promote an EHS culture to ensure departmental activities align with internal and external EHS standards.

• Ensure compliance with procedures in their domain.

• Identify and anticipate risk situations by proposing preventive actions.

• Prepare for and participate in audits and inspections, contributing to defining associated responses.

Quality :

• Ensure compliance with GSK group standards and policies in all operational activities at the Saint Amand site.

• Develop and deploy site Quality standards in business areas in accordance with internal and external Quality/Regulatory standards.

• Promote a Quality culture focused on first-time excellence and continuous improvement to enhance customer satisfaction.

Costs:

• Establish the annual budget for the department and optimize allocated resources.

• Plan and implement cost controls within their areas of responsibility.

• Promote profitable growth based on Quality and Productivity.

Timelines:

• Implement quality systems enabling effective Quality monitoring close to the field.

• Ensure team performance through adequate coordination, resource allocation, and performance monitoring.

Specific Activities:

The Site Quality Director/Operational Quality:

• Is a member of the Management Committee and contributes to strategic decision-making.

• Ensures the smooth operation and evolution of the organizational system in their unit, foreseeing necessary adaptations.

• Organizes and facilitates monthly "Quality Councils" and Quality service meetings.

• Reports site activities to Global QA through various quality reports and indicators.

• Provides necessary support to the Responsible Pharmacist Group (QP) for annual product quality reviews.

Required Profile:

Education and Experience :

• Minimum (Baccalaureate+5), specialization in industrial pharmacy.

• Minimum 10 years of experience in Production/Quality Assurance in the pharmaceutical industry.

• Experience in quality control (at least 6 months) and demonstrated team management.

• Experience in international project management and multiple positions held in the quality or production field.

Skills and Knowledge:

• Proficiency in aseptic processes and GMP/cGMP in the pharmaceutical industry.

• Experience working in a network with global functions and international sites.

• Fluent in English (daily usage).

Other Required Skills:

• Expertise in GMP, GSK, GMP, and regulatory standards to ensure high-quality vaccines.

• Knowledge of labour laws and EHS regulations.

• Ability to solve complex problems and make decisions under pressure.

• This role also requires strong interpersonal skills, the ability to represent the company externally and internally, and work in an international and matrixed context.

To Apply:

*LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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