Location: Portugal - Amadora
Function: Research and Development
Company: 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.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.