Senior Manager, Development Country Quality
Opportunité Professionnelle : Senior Manager, Development Country Quality
Aperçu de l’Emploi
Titre du Poste : Senior Manager, Development Country Quality
Entreprise : Alexion Pharmaceuticals
Localisation : Ataşehir, İstanbul
Date de Publication : 9 mai 2025
Description du Poste
Le poste de Senior Manager, Development Country Quality au sein d’Alexion Pharmaceuticals est crucial pour garantir la qualité et la conformité des opérations cliniques au niveau national. Sous la direction du Directeur/Directeur Associé de la Qualité au niveau pays, le titulaire sera chargé de fournir un soutien en matière de gestion de la qualité dans le cadre des essais cliniques, tout en favorisant une culture axée sur la gestion des risques et la qualité basée sur les données.
Les missions clés incluent :
- Support à la culture de conformité réglementaire durable à travers l’application de principes de gestion de la qualité basés sur le risque.
- Évaluation proactive des processus pour optimiser l’efficacité, en collaboration avec les propriétaires de processus métier et l’organisation de gestion des opérations cliniques.
- Conseil en matière de conformité clinique pour l’équipe COM, en identifiant des indicateurs clés de qualité (KQIs) au niveau des pays et des sites.
Responsabilités Principales
Le Senior Manager DCQ jouera un rôle essentiel dans plusieurs dimensions de la qualité opérationnelle :
- Développement et mise en œuvre de documents procéduraux locaux, en maintenant une connaissance approfondie des réglementations locales et des pratiques de l’industrie.
- Collaboration avec les équipes d’étude pour gérer et résoudre les problèmes de qualité et de conformité.
- Participation active à la préparation et à la gestion des audits et inspections réglementaires, garantissant une communication efficace des résultats.
- Identification des risques potentiels en se fondant sur des résultats d’audits précédents et des travaux de gestion de la qualité.
Profil Recherché
Les candidats doivent posséder les qualifications suivantes :
- Diplôme : Licence en sciences de la vie ou dans un domaine équivalent.
- Expérience : Minimum de 5 à 8 ans dans le domaine de la recherche clinique, y compris la conformité aux Bonnes Pratiques Cliniques (GCP).
- Connaissance : Bonne connaissance des réglementations GxP/GCP (EMA, FDA, PMDA, etc.) et expérience avec les évaluations de risque et la gestion CAPA.
Compétences Préférées : Un diplôme avancé ainsi que des compétences en communication, en pensée critique, et en résolution de problèmes seront un atout.
Engagement en matiére de Diversité
Alexion Pharmaceuticals est engagé à promouvoir la diversité et l’égalité des chances. L’entreprise valorise toutes les candidatures, quelles que soient leurs caractéristiques, et se conforme à toutes les lois et régulations en matière de non-discrimination.
Rémunération et Candidature
Le salaire pour ce poste n’est pas spécifié, mais le rôle propose des perspectives intéressantes dans un environnement dynamique. Les candidats intéressés sont invités à postuler via le lien ci-dessous :
Ce poste représente une occasion d’intégrer une équipe dédiée à l’innovation et à l’excellence dans le secteur pharmaceutique, tout en contribuant à des projets au service de la santé.
📅 Date de publication de l’offre : Fri, 09 May 2025 22:08:30 GMT
🏢 Entreprise : Alexion Pharmaceuticals
📍 Lieu : Ataşehir, İstanbul
💼 Intitulé du poste : Senior Manager, Development Country Quality
💶 Rémunération proposée :
📝 Description du poste : This is what you will do:
- Under the direction of Director/ Associate Director Development Country Quality, the Senior Manager Deveolopment Country Quality is accountable as Clinical Operations Management (COM) quality support and is responsible for supporting a culture of data and risk driven quality oversight of the clinical trials. The Senior Manager, DCQ is responsible for providing quality-focused guidance for execution of Rare Disease Business Unit at the country and site level.
- The Senior Manager Development Country Quality (Sr Manager DCQ) may be asked to actively engage with Country Operations Team to support a culture of sustainable regulatory compliance at country and site level via the risk-based quality management principles within and across portfolio.
The Senior Manager DCQ will be responsible for proactive process efficiencies’ assessment and building remediation/optimization in partnership with business process owners and COM organization as applicable. * The Senior Manager DCQ will act as clinical compliance advisor/partner to the COM team. This role will work closely with COM Team and Study DAQs to proactively identify country level Key Quality Indicators (KQIs) and develops mechanisms of KQI oversight and trending.
- This role will collaborate closely with Study Quality DAQs and risk/issue owners to assure systemic and systematic risks and issues are communicated in a timely manner to be managed through action and resolution.
You will be responsible for:
- In alignment with (Associate) Director Development Country Quality, the Senior Manager DCQ supports execution of an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio across all Therapeutic Area(s) (TAs) at a country level.
- Provide Quality advice to Clinical Operations Management (COM) group globally related to GCP compliance of COM processes and their continuous improvements.
- The Senior Manager DCQ is responsible for the development, implementation and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials.
- In support with AD DCQ, Senior Manager DCQ provides advice to Local Study Teams on procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations.
- Support local management in the planning and conduct of local quality control activities including but not limited to performing accompanied site visits. Oversees and supports QC visits / QC activities with local staff and maintains the annual quality plan updated.
- Work closely with COM team and other quality partners to proactively identify country level Key Quality Indicators (KQIs). Develops mechanisms of KQI oversight and trending. Provide local COM with information regarding status of quality issues and quality trends observed in COM.
- Collaborate with other quality representatives and support local study teams to resolve quality and compliance issues.
- In support with AD DCQ, Sr Manager DCQ engages in the preparation for conduct of and responses to audits and regulatory inspections.
- Give regular feedback and Lessons Learned on audit and inspection findings to relevant COM and regional quality network.
- Identify and ensure resolution of potential risks based on previous study/systems QC results, audit and inspection results and current routine quality management work.
- Supports AD DCQ in identifying and organizing on-going and ad hoc training of local staff according to local training needs, in cooperation with local COM leadership:
- Introductory training to new staff, including Procedural Training,
- ad hoc local training solutions e.g., as result of serious or recurring quality issues.
You will need to have:
- Bachelor’s degree in life science, or equivalent field, required.
- Minimum of 5-8 years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance.
- Good knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)
- Relevant experience with GxP investigations, risk assessments and CAPA management.
- Experience participating in regulatory inspections.
- Experience with multinational products and regulations as well as with mandated risk management plans.
- Ability to travel up to 20%.
We would prefer for you to have:
- Advanced degree preferred
- Competencies to be successful for this position include:
- Quality, process, and compliance oriented
- Strong interpersonal skills
- Critical thinking
- Integrity
- Communication
- Teamwork
- Problem solving
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
🔎 Offre d’emploi vérifiée et enrichie selon la ligne éditoriale de l’Association Artia13 : éthique, inclusion, transparence et vigilance contre les annonces trompeuses.
🌍 Retrouvez d’autres offres sur artia13.world
