The purpose of the job is to manage the Document & Data, Change and Exception Management department at the Vienna plant and to implement the Quality Management System elements in alignment with global
Lead and develop the following teams:
- Change Control Management
- Deviation Management (including Non-conformance-, OOS- and H-Management)
Quality Risk Management
Document & Data Management
This position is entrusted with the following daily job functions:
- Assure compliance of Vienna Quality Systems (Non-conformance Management, Change Control, Quality Risk Management, Document & Data Management) with international guidelines and Shire Global Quality Standards
- Assure that Shire Global Quality Standards are implemented in a timely manner
- Assure support of operations departments regarding Quality Systems
- Represent with the team members Quality Systems topics during internal audits and external inspections
- Support response preparation and track observations resulting from internal audits and external inspections
- Assure that the Quality Systems are working in all areas of the Vienna plant as expected
- Drive continuous improvement for Quality Systems
- Handle interfacility changes as gatekeeper-department
- Keep good relationship with customer departments and offer timely support
Education and Experience Requirements/Key Skills, Abilities and Competencies:
- Essential: Good experience in quality assurance, validation, good knowledge of GMP requirements as well as understanding of the quality requirements in the area of manufacturing, plant utilities, computer systems and project management. Experience with managing regulatory inspections. At least 3 years practical experience in these fields in a pharmaceutical company.
- Desired: Graduated from a technical, chemical or biological college or university with practical experience of quality operations function or related area.
- Excellent change management and people management skills as well as strong communication and technical skills. Additional special requested skills are: competence, responsibility, accuracy, reliability, good command of English and German
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.
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 € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application.