Shire Quality Manager (f/m) Sanaplasma – Czech Republic & Hungary in Prague, Czech Republic

Sanaplasma s.r.o. was recently acquired by Shire, a leading global biotechnology company in the field of rare diseases, and will operate as part of the Shire BioLife plasma center division. As Quality Manager you will be responsible for the implementation and maintenance of the Quality Management System for 11 plasma centers in the Czech Republic and 3 plasma centers in Hungary.

About the position:

  • Quality Assurance according to local and European regulations of Czech and Hungarian plasma centers as well as GMP requirements

  • Disciplinary leadership of approx. 5 Quality Management Representatives in different plasma centers in the Czech Republic and Hungary

  • Training, motivation, development and coaching of your team

  • Manage and ensure that written instructions are available for operative and administrative processes, for test procedures and audits, and for the use of the 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

  • Representation of the area of responsibility in the course of inspections and audits

  • Participation in congresses, symposiums, and customer oriented events

Skills you need:

  • Education in Natural Sciences (e.g. Medicine, Chemistry, Biologics)

  • At least 5 years of experience in Quality Assurance, ideally in a plasma sourcing business or a pharmaceutical company

  • Experience with the leadership of teams, preferably in an international environment

  • Knowledge on operational, quality, or regulatory responsibility as well as legal requirements in plasma sourcing business in Europe (Czech Republic, Hungary, Austria)

  • Experience with negotiating with regulatory agencies

  • Fluent in Czech and English, good command of Hungarian and 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

  • Willingness to travel 60% - 70% of your working time (Czech Republic, Hungary, Vienna), the rest can be managed either from the Sanaplasma main office in Brno or by 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 trainee and training programs, work-life balance, etc. Here you can learn more about Shire in Austria. at https://youtu.be/ly_8oO-iJeU

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success.

Depending on your qualification and experience the base salary for this position will range around CZK 90.000 gross per month (full-time) plus bonus. We are looking forward to your application!

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.