Lieu: Portugal - Amadora
Fonction: Research and Development
Compagnie: OM Pharma
For our manufacturing site in Portugal, we are currently looking for a Clinical Trial Supplies Project Manager. In this interesting function, you are responsible for the management of all activities related to IMP Packaging. You are responsible for clinical trial supply deliverables and other relevant associated sub-functions, and you have operational end to end responsibilities. Furthermore, you oversee multiple projects and actively participate in cross-functional teams. Your main tasks are the following:
- Lead the local IMP Packaging / Logistics Team and act as interface to internal manufacturing specialists, to internal QA and Clinical Supplies Logistics experts, as well as to external contractors and service providers, and to the Clinical Trial Supplies Management Team at HQ
- Be responsible to define and establish the processes and SOP’s to set up a new, efficient internal IMP Packaging site as per current standards
- Create and maintain all Packaging Documentation for assigned studies based on packaging request from HQ Clinical Trials Supply Management Team, in alignment with protocol requirements, key study parameters and milestones
- Be in charge of providing up to date project timelines for each packaging campaign, to book packaging slots for timely packaging, and to make sure all required products are available in time
- Oversee and perform line unit checks of GMP documentation
- Develop and evaluate blinding strategies
- Support label proof approvals processes
- Evaluate and establish external contractors and service providers as required, ensure timely ordering of packaging materials, labels and booklets, auxiliary materials and comparators
- Oversee the local inventory, provide reports as requested, and support reconciliation processes as needed
- Identify, assess and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
- Support optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions
- Support an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies
For this role, we are looking for a flexible and good organized person with the following profile:
- University degree in Lifesciences, Pharmacy, Biochemisty, Chemistry or similar
- At least 5 years’ experience in a similar Clinical Trial Supply Management position, within a global pharmaceutical or biotech industry
- Previous experience in Senior position with people management
- Very good knowledge of GMP, GCP and GDP environment
- Fluent in Portuguese and English both in oral and written conversation
You describe yourself as a very autonomous person, able to work in a changing environment and under pressure. Thanks to your good communication skills, you can work efficiently in a cross-functional organization and achieve performance. As a leader, you like to coach and motivate your team, to plan tasks and to take care of the budget.
A propos de nous
Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.
Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.
Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.
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