For Our Brussels site and under the authority of the QA Director, we are looking for a highly skilled and motivated Site Quality Senior Manager to reinforce our team.You will play a crucial role in ensuring the overall quality and compliance of our organization's operations.The successful candidate will be responsible for identifying, assessing, and managing risks related to product quality and regulatory compliance.You will collaborate with cross-functional teams to develop and implement risk mitigation strategies and drive continuous improvement initiatives.The Quality Risk Manager will also be responsible for maintaining effective communication channels with internal stakeholders, regulatory agencies, and external partners.The RoleQuality TransformationDevelop and implement quality transformation strategies: You will be responsible for designing and implementing strategies to improve quality standards across the organization. This includes identifying areas for improvement, setting goals, and developing action plans.Process optimization: You will work closely with cross-functional teams to identify and streamline processes that impact quality. This may involve conducting process audits, analyzing data, and implementing process improvements to enhance efficiency and effectiveness. This includes developing and implementing policies, procedures, and guidelines to ensure compliance.Training and development: You will provide support to the training team to enhance their understanding of quality principles and practices. This may involve conducting workshops, creating training materials, and facilitating knowledge sharing sessions.Performance monitoring and reporting: You will monitor key quality metrics and performance indicators to assess the effectiveness of quality improvement initiatives. Regular reporting and communication of results to stakeholders will be essential to drive accountability and transparency.Change management: As a Quality Transformation Manager, you will play a critical role in managing change within the organization. This involves engaging stakeholders, addressing resistance, and driving a culture of continuous improvement.Risk ManagementDevelop and implement a comprehensive site Quality Risk Management program in alignment with regulatory requirements, industry best practices and corporate initiatives,Identify and assess potential risks to product quality, regulatory compliance, and patient safety across the organization,Conduct risk assessments, including the identification of hazards, estimation of risks, and evaluation of risk mitigation strategies,Collaborate with cross-functional teams to develop and implement risk mitigation plans,Monitor and review risk management activities, including the effectiveness of implemented controls and corrective actions,Provide guidance and support to teams in identifying and addressing quality-related risks during product development, manufacturing, and distribution processes,Facilitate risk management training and workshops to enhance risk awareness and foster a culture of quality and compliance,Stay up-to-date with industry trends, regulatory changes, and emerging risks, and proactively recommend improvements to the quality risk management program,Establish and maintain effective communication channels with internal stakeholders, regulatory agencies, and external partners regarding quality risk management matters,Participate in internal and external audits and inspections, providing necessary documentation and support as required,Report and escalate to the site leadership team the emerging risks.The CandidateMinimum of 10 to 15 years of experience in various quality related area, such as quality assurance, quality systems, quality control, risk management, or a related field within the pharmaceutical, biotechnology, or medical device industry,Being a pharmacist eligible as a qualified person,Effective communication and interpersonal skills, with the ability to collaborate and influence stakeholders at all levels of the organization,Strong organizational abilities, with the ability to prioritize and manage multiple tasks simultaneously and evolve in a fast-changing environment,Excellent analytical, problem-solving, and decision-making skills,Familiarity with relevant regulations and standards,Strong knowledge of quality risk management principles, methodologies, and tools (e.g., FMEA, HACCP, Ishikawa diagrams),Experience in conducting risk assessments and developing risk mitigation strategies,Data-oriented mindset with a focus on continuous improvement and compliance,Professional certifications related to quality management and risk assessment (e.g., Six Sigma, ASQ, RAPS) are desirable,Fluent in English, French/Dutch preferred.Position benefitsWhat we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry – a sterile businessPotential for personal development within an international companyDefined career path and annual performance review and feedback processContributory pension and benefits package all offered from day one of employment (health/group insurance)Meal Vouchers, Eco Voucher, Company Car36 days’ holiday + bank holidaysCatalent’s standard leadership competencies that are used to interview and for Performance & Development:Delivers ResultsLeads with Integrity and RespectDemonstrates Business AcumenFosters Collaboration and TeamworkChampions ChangeEngages and InspiresCoaches and DevelopsCatalent offre des opportunités enrichissantes pour faire avancer votre carrière! Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.Initiative personnelle. Rythme dynamique. Un travail significatif.Visitez pour explorer les opportunités de carrière.Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.Si, en raison d’un handicap, vous avez besoin d'un aménagement raisonnable pour une partie ou plus du processus de candidature ou d'embauche, vous pouvez soumettre votre demande en envoyant un courriel et en confirmant votre demande d'aménagement et en incluant le numéro de poste, le titre et le lieu à . Cette option est réservée aux personnes ayant besoin d'un aménagement en raison d'un handicap. Les informations reçues seront traitées par un employé de Catalent aux États-Unis, puis acheminées vers un recruteur local qui fournira une assistance pour assurer une prise en compte appropriée dans le processus de candidature ou d'embauche.Avis aux représentants des agences et des cabinets de recherche : Catalent Pharma Solutions (Catalent) n'accepte pas les curriculum vitae non sollicités d'agences et/ou de cabinets de recherche pour cette offre d'emploi. Les curriculum vitae soumis à tout employé de Catalent par une agence tierce et/ou une société de recherche sans un accord de recherche écrit et signé valide, deviendront la propriété exclusive de Catalent. Aucuns frais ne seront payés si un candidat est embauché pour ce poste à la suite d'une recommandation non sollicitée d'une agence ou d'un cabinet de recherche. Merci.
