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Quality Manager (f/m/x) Sanaplasma – Czech Republic
Sanaplasma s.r.o. is part of Takeda, a leading patient-focused, values-based, R&D-driven global biopharmaceutical company in the field of rare diseases and is operating as part of BioLife Europe, the plasma center division. In this challenging position you will be responsible for the implementation and maintenance of the Quality Management System for currently 11 plasma centers in the Czech Republic.
Quality Assurance according to local SUKL and European regulations as well as GMP requirements for all Czech plasma centers
Leading, training, motivating, developing and coaching a team of 5 local Quality Management Representatives in different plasma centers in the Czech Republic
Ensure that written instructions are available for operative and administrative processes, test procedures, audits and the use of correct auxiliary materials
Decisions on implementation of overarching procedures in consultation with the members of the Quality Assurance BioLife Europe Leadership Team
Support the Operational Excellence team for continuous improvement activities by providing GMP and QA consultation
Provide assurance that plasma is collected, tested and released in accordance with the local regulations and with the requirements of the Product Marketing Authorizations
Main contact person for Quality topics for inspections and audits
Participation in congresses, symposiums and customer-oriented events
Your Skills and Qualifications:
Education in Natural Sciences or Technology (e.g. Medicine, Chemistry, Biologics)
Ideally 3 years of experience in Quality Assurance, ideally in a plasma sourcing business, a pharmaceutical company or a similar industry
Experience with the leadership of teams, preferably in an international environment
Knowledge of operational, quality, regulatory as well as legal requirements in plasma sourcing business in Europe
Experience with negotiations with regulatory agencies
Fluent in Czech and English, command of German is beneficial
Strong communication and motivation skills
Good at working with people of diverse backgrounds
Strong quality and service orientation
Very good knowledge of MS Office
Ability to work efficiently in a fast-paced environment
Willingness to travel up to 60% of your working time (Czech Republic, Vienna/AT), the rest can be managed either from the Sanaplasma main office in Brno, one of the Sanaplasma centers or from homeoffice
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as meal vouchers, Cafeteria, public transport allowance, etc. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities.
This position will be placed under a Czech contract of employment with an appropriate salary in CZK.