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.
- 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
- 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.
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.