Customer Program Quality Manager
Opportunité Professionnelle : Customer Program Quality Manager chez Fujifilm
Présentation de l’Annonce
Fujifilm, un leader mondial dans le secteur du développement et de la fabrication de produits biologiques, recherche un Customer Program Quality Manager pour rejoindre son équipe à Hillerød, au Danemark. Ce poste est conçu pour des professionnels en assurance qualité expérimentés, désireux de collaborer avec des entreprises biopharmaceutiques et de garantir l’excellence dans la fabrication des substances médicamenteuses, des produits finis et des emballages.
Description du Poste
Le Customer Program Quality Manager agira en tant que point de liaison entre les clients et l’équipe interne de Fujifilm. Le candidat retenu sera chargé de superviser les aspects qualité associés à chaque projet, garantissant ainsi que les clients sont informés et impliqués tout au long des processus de transfert technologique.
Les responsabilités incluent, mais ne se limitent pas à :
- Être le principal contact des clients sur les sujets liés à la qualité, notamment durant le processus commercial et le transfert technique.
- Faciliter les discussions avec les clients concernant les écarts, les changements, les CAPAs (Corrective and Preventive Actions), et les plaintes.
- Préparer et participer aux visites et audits des clients.
- Contribuer à la révision des accords de qualité existants et soutenir les activités de fabrication.
- Établir et maintenir la documentation de département, y compris des présentations clients et des procédures opérationnelles standard (SOP).
Compétences Requises
Le candidat idéal devra posséder :
- Un diplôme de master en biochimie, biologie, biotechnologie, sciences pharmaceutiques ou un domaine connexe, avec une connaissance des systèmes de qualité et des Bonnes Pratiques de Fabrication (GMP).
- Un minimum de 5 à 10 ans d’expérience pertinente en assurance qualité.
- Une maîtrise de l’anglais, langue de travail au sein de l’entreprise.
- Un sens aigu des affaires et une capacité à gérer efficacement les parties prenantes dans un environnement dynamique.
Équipe et Environnement de Travail
Le poste se situe au sein d’une équipe de Program Quality Management (MFG) composée de 10 membres hautement qualifiés, chacun apportant une contribution précieuse au secteur de la fabrication pharmaceutique. L’atmosphère de travail est à la fois internationale et informelle, favorisant un équilibre entre vie professionnelle et vie personnelle et mettant l’accent sur la sécurité psychologique.
Engagement en matière de Diversité et d’Égalité des Chances
Fujifilm Diosynth Biotechnologies s’engage à offrir un environnement de travail équitable. Chaque candidat, quelles que soient ses origines, recevra une égale considération dans le processus de recrutement. Ce principe s’applique sans discrimination aucune, affirmant la valeur de la diversité au sein de l’entreprise.
Application et Contact
Si cette opportunité vous intéresse, nous vous encourageons à soumettre votre CV et lettre de motivation dès que possible. Les candidatures seront évaluées en continu, et l’annonce sera retirée une fois le bon candidat identifié. Pour toute question, vous pouvez contacter Annelise Olsen, Responsable de la Program Quality Management, au +45 41945471.
Pour postuler, veuillez suivre ce lien : Postulez dès maintenant !
Ce poste constitue une excellente opportunité pour les professionnels qualifiés souhaitant jouer un rôle clé dans l’amélioration de la qualité et l’impact positif sur le secteur biopharmaceutique.
📅 Date de publication de l’offre : Sat, 31 May 2025 22:43:28 GMT
🏢 Entreprise : Fujifilm
📍 Lieu : Hillerød, Hovedstaden
💼 Intitulé du poste : Customer Program Quality Manager
💶 Rémunération proposée :
📝 Description du poste : Are you an experienced Quality Assurance professional with a passion for collaborating with biopharma companies and ensuring cutting-edge quality in Drug Substance, Drug Product, and Finished Goods manufacturing?Do you thrive in dynamic settings where you can be the pivotal link between customers and your team, driving discussions and ensuring seamless communication on all quality-related topics?Then we hope you will join the Program Quality Management team for Manufacturing (PQM MFG)!Your New RoleWe work with various biopharma companies, which means each project we work on brings a unique set of tasks. You will be the link between our customers and our FDB team.You will be involved in all quality related topics related to the Tech Transfer affecting customer’s programs and make sure customers are informed and involved to feel confidence in our collaboration. You will interact with highly skilled personnel to support your communication on complex activities. We continuously strive to identify opportunities to improve systems and practices and provide direction to our manufacturing group as well as technical development teams and our customers.You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact.Main Responsibilities
- Be the primary point of contact to customers regarding quality related topics both during commercial and Tech Transfer processes
- Drive discussions with customers to support ongoing activities for example on deviations, changes, CAPAs, complaints
- Be a link between customer and internal organization; preparing upcoming communication with customers on specific quality topics
- Support revision of existing Quality Agreements
- Support manufacturing activities including representing quality assurance in the core team for the program
- Prepare and participate in customer visits and audits
- Establish, develop and maintain department documents: customer presentations, SOPs and participate in our internal Continuous Improvement activities
- Ad hoc tasks
Skills & Knowledge, we hope you possess
- A masters degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems
- A minimum of 5-10-year relevant QA experience.
- Fluency in English is required as English is our corporate language.
- This role requires that you facilitate operational elements in the actual program execution. It requires a personality that induce sufficient business acumen and process insight to drive, facilitate, and manage stakeholders across the entire business with authority and charisma.
We hope you area positive and organized team player with a keen eye for detail and a natural ability for keeping the overview in a dynamic environment.Your New Team & DepartmentThe Program Quality Management (MFG) team consists of 10 highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. The team is an organization embedded in the Quality organization under Program Quality and provides quality support to production of engineering, clinical, PPQ and commercial batches in large scale Drug Substance manufacturing, filling of Drug Product and Assembly, Label and Pack.The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.Your applicationDoes this sound interesting? Then please upload your CV and cover letter as soon as possible, as we will continuously invite relevant candidates for job interviews. The job advertisement will be removed when the right candidate has been identified.In case you have any questions, please do not hesitate to contact Head of Program Quality Management, Manufacturing, Annelise Olsen +45 41945471FUJIFILM Diosynth Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.Our success starts with our people — their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.Shape the future with us — your drive meets boundless opportunity hereFUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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