Managing all aspects of Quality in Operations at the Vienna facility (Fractionation, Purification, Pharmaceutical Production, Finishing), ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), Shire and other regulatory quality standards and requirements
- Staffing, organization and development of Quality personnel (> 50 QA employees, 6 QA Manager)
- Achievement of defined goals and targets in order to drive the Vienna plant to reach operational and compliance excellence
- Setup Goals and projects for team members to achieve daily operations goals as well as strategic (Vienna plant and Shire) quality goals
- Report to Facility Quality Management Representative on a routine basis the goals, achievements, gaps and opportunities for improvement
- Manage and direct all aspects of Quality in Operations at the Vienna facility, implement Shire strategy within the area of responsibility
- Manage budget within area of responsibility incl. financial improvement
- Cooperation with other Shire facilities and process related facilities
- Drive and manage continuous improvement within the area of responsibility.
- Be member of Vienna Quality Management Review team incl. evaluation of trends and setting of corrective and preventive measures
- Be member of ERB (Event review board), CAPA review board, complaint board and daily Tier 3 Meetings to drive root cause investigation and support timely product Release
- Support CMO business (Vaccines for Pfizer, Biosurgery for Baxter) at the Vienna plant
- Leading problem solving activities
- Presentation/defending of several topics during internal/external regulatory inspections
- Master Degree in Science (e.g. Biotechnology, Chemistry, etc.)
- Fluent German and English skills
- Process knowledge (Plasma fractionation, purification, pharmaceutical production, visual inspection, packaging, Mediafill supervision)
- cGMP and Quality system knowledge (Change Control, Batch Record Review, deviation management, documentation, GMP walks)
- Experience with internal/external regulatory inspections (e.g. US FDA)
- Leadership experience > 5 years and large teams
- Soft skills (proactive problem solver, effective communicator, focus on results, decision maker, motivator, stress resilience, emotional intelligence, self-awareness, wants to learn, positive thinker, team player)
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 according to collective agreement for this position is € 4.094,41 gross per month (full-time); increased payment is intended; in addition we offer an attractive monetary incentive program. We are looking forward to your application.