Shire Manager Quality Control (f/m) in Orth an der Donau (Baxalta), Austria

This role will serve as the Global Quality Control Operations Lead Orth Lab for the Shire multi-product testing hub in Orth, Austria. This facility is testing plasma derived, recombinant and gene therapy products in different development phases and commercial.

This role is primarily responsible for leading the QC operations, QC method validation and transfers, support and authoring of regulatory submissions and leading investigations and problem solving together with site QC labs and partners from Global QC. This is a critical role within the Quality Control organisation to help create value for our patients.

Main Tasks:

  • Organize operations especially in lieu with continuous improvement

  • Build processes and procedures to facilitate the transfer of analytical methods to Quality Control laboratories within the Shire Network (Analytical, Biochemical, Cell Biology, Microbiology and Raw Materials)

  • Drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of operational and development goals

  • Partner with cross functional stakeholders such as Method Introduction and Site Support (MI&S) and key groups in global Quality Control (e.g. Analytical Instrument Qualification (AIQ), Quality Control Technical Services (QCTS), etc.) as well as the Analytical development and Regulatory Affairs groups

  • Drive decision making with all stakeholders and take decisions including risk management for method implementation and site support

  • Assure GMP compliance

  • Support Audits, assure inspection readiness

Requirements:

  • A minimum of a Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering). A post-graduate qualification (MSc. or PhD) is desired

  • Experience in the biotechnology and/or pharmaceutical industry, with Operational experience of quality laboratories in a fast moving manufacturing environment and demonstrated project management experience

  • Experience of analytical transfer programs and method development/validation

  • Proactive at keeping current with literature and latest technologies

  • A background in analytical methods (HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis and compendia assays)

  • Knowledge of Analytical Method Development, Analytical Method Validation and Statistical Quality Control. An excellent understanding of GMP, ICH, USP and global compendia regulations

  • Experience leading, training and/or implementing root cause analysis and effective investigation practices.

  • Fluent in German and English language is a must, communication in multiple languages (French, Italian) would be a benefit

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, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, 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.

The minimum salary for this position is € 4.225,44 gross per month (full-time); increased payment is possible. 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.