Quality Compliance Director - Biologics & Devices

Ce poste est publié en anglais et en français. Le manager n'étant pas francophone, merci de transmettre votre CV en anglais.

VERSION FRANCAISE

Directeur de la Conformité Qualité – Biologiques & Dispositifs (B&D)

Le rôle assure un leadership et une orientation stratégique afin de garantir que la Qualité des Biologiques & Dispositifs se fait en conformité avec les normes de GSK. Il reportera directement au Vice-Président, Qualité Biologiques & Dispositifs.

Responsabilités

En tant que Directeur de la Conformité Qualité B&D, vous :

• Dirigez la performance et la conformité qualité pour l’unité opérationnelle, en surveillant les KPI et en prenant des mesures correctives si nécessaire.

• Assurez que les incidents sont correctement signalés, gérés et communiqués aux autorités.

• Apportez un soutien dans l’évaluation de l’impact des déviations critiques.

• Veillez à ce que les risques qualité des produits de l’unité opérationnelle soient identifiés, compris et maîtrisés, et que le Modèle de Risque Qualité soit utilisé efficacement.

• Agissez en tant qu’interface propriétaire des processus métier pour les systèmes et processus qualité, en collaborant avec les responsables qualité des équipes mondiales.

Dans ce rôle, vous :

• Soutenez la mise en œuvre de la stratégie qualité pour B&D Qualité.

• Contribuez à la performance et à la culture qualité en veillant à ce que les tendances négatives des tableaux de bord de conformité soient analysées et corrigées. Participez aux inspections des sites selon les besoins.

• Supervisez et présidez les processus pour garantir que les incidents sont correctement escaladés et gérés, et soutenez les décisions clés en matière de qualité.

• Agissez en tant que propriétaire local des systèmes qualité de l’entreprise, en assurant l’interface clé entre la qualité B&D et l’équipe Qualité Systèmes et Données.

• Êtes responsable du processus du Conseil Qualité et veiller à ce que l’ordre du jour et les escalations soient appropriés pour améliorer les processus et atténuer les risques. Garantissez l’amélioration continue du processus QC.

• Supervisez la réunion de Performance Qualité pour assurer la compréhension des indicateurs qualité, identifier et résoudre les tendances, et améliorer la conformité, notamment en dirigeant l’examen trimestriel des tendances de déviations et en coordonnant les CAPA et actions régionales.

Pourquoi vous ?

Qualifications et compétences de base

Nous recherchons des professionnels avec les compétences requises suivantes :

• Diplôme en Sciences Biologiques, Chimie, Pharmacie ou disciplines scientifiques connexes.

• Expérience significative en Qualité dans un environnement hautement réglementé.

• Expérience en Qualité Produit et Conformité.

• Expérience dans les Opérations de Fabrication.

• Connaissance des cGMP à l’échelle mondiale.

• Connaissance des produits CEP.

• Maîtrise et application du Système de Management de la Qualité (QMS).

• Excellentes compétences en gestion des parties prenantes et en influence.

Qualifications et compétences souhaitées

Ces compétences ne sont pas obligatoires, mais seraient un atout :

• MSc, PhD ou autre qualification professionnelle en Sciences Biologiques, Chimie, Pharmacie ou disciplines connexes.

• Connaissance des outils d’Excellence Opérationnelle et de la gestion des KPI.

• Excellentes compétences en gestion, communication et relations interpersonnelles, avec aisance à collaborer avec des interlocuteurs internes et externes à tous niveaux organisationnels.

• Expérience dans la définition des objectifs et l’obtention de résultats, la gestion des priorités, et l’influence sur la performance individuelle et collective.

• Maîtrise de l’anglais, à l’écrit comme à l’oral.

Veuillez conserver une copie de cette description de poste, car elle ne sera plus disponible après la clôture de l’annonce.

Le manager n'étant pas francophone, merci de transmettre votre CV en anglais.

ENGLISH VERSION

Quality Compliance Director – Biologics & Devices (B&D)

The role provides leadership and direction to ensure the Biologics & Devices Quality operates in compliance with GSK standards. It will report into the VP, Quality Biologics & Devices As Quality Compliance Director B&D, you:

• Lead Quality performance and compliance for the operational business unit, monitoring the KPI Performance and initiating action as required.

• Ensure incidents are appropriately escalated, managed, and communicated to the authorities.

• Provide support in assessing the impact of critical deviations.

• Ensure the Quality risks for the business unit products are identified understood and managed and that the Quality Risk Model is used to effectively identify and manage risk.

• Act as the Business process owner interface for quality systems and processes, partnering with quality leaders across global teams.

In this role you will:

• Support the implementation of the quality strategy for B&D Quality.

• Contribute to quality performance and culture ensuring adverse trends in compliance dashboards are investigated and action taken. Support site inspections as required.

• Oversight/ Chair for PIRC and LIC process ensuring incidents are properly escalated and managed and supports key quality decisions.

• Local business owner for enterprise quality systems, a key interface between B&D quality and Quality Systems and Data team.

• Accountable for the Quality Council process for B&D Quality, and leads Regional Quality ensuring agenda and escalation are appropriate to drive improvement and mitigate risks. Ensure that QC process is continuously improved.

• Accountable for the Quality Performance meeting ensuring that all the quality metrics are understood, trend identified and resolved, and status of compliance improved, including leading Quarterly Deviation Trend review and coordinating regional CAPAs and actions

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Degree qualified in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines

• Significant experience in a Quality in highly regulated environment

• Experience in Product Quality and Compliance •

• Experience in Manufacturing Operations •

• Knowledge of cGMP globally •

• Knowledge of CEP products •

• Knowledge and application of the QMS

• Strong stakeholder management and influencing capabilities

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• MSc or PhD or other Chartered / Professional Qualification in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines

• Knowledge of OE tools and KPI management

• Excellent management, communication and interpersonal skills, with comfort cooperating with individuals internally and externally at all organisational levels.

• Experience setting goals and driving results, defining priorities, managing and influencing individual and team performance.

• Fluency in English both Written and Spoken

Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
 

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Fr-diversity.recruitment@gsk.com​

Please note should your enquiry not relate to adjustments; we will not be able to support you through these channels.

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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