- Manages the Quality organization (about 300 people) and supports cascaded implementation of Corporate policies and initiatives. Responsible for results in terms of product quality and conformance to regulations and Corporate policies. Serves as the Quality Management Representative (QMR) for the Vienna, Austria Facility
- Develops and deploys the quality systems (e.g. Management Review, CAPA, Change Control, Document Control, Process Control, Release, Complaint Management etc.) that ensure products conform to defined requirements
- Understands and deploys processes to assure conformance to regulations. Manages regulatory inspections
- Periodically reviews the suitability and effectiveness of the quality system with and escalates critical product quality and compliance concerns to Corporate Senior Management
- Interacts frequently with all levels of internal facility management as well as across functions, franchises and business units
- Manages interactions with customers and regulators concerning the quality of products, systems and processes
- Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility
- Has Authority to stop production and prevent release of products if safety, purity and efficacy of products cannot be guaranteed
- Develops budget for large size facility or large programs/department and ensures adherence to the budget
- In depth knowledge of the local and international regulatory environment for manufacture of biological/plasma derived products
- Strong leadership skills and demonstrated success in managing a large team
- Strong analytical and (demonstrated) problem solving skills.
- Excellent verbal and written communication skills in English. German language skills beneficial (German speaking site)
- Success working with multifunctional, global teams
- Excellent interpersonal/communication/influencing/negotiation skills required
- BS in Science or Engineering; advanced degree helpful. Minimum of 10 year experience in Quality, Aseptic Manufacturing or related field in the pharmaceutical industry, preferably plasma industry. Minimum of 7 years management experience
- Experience in managing major regulatory inspections such as FDA
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 € 140.000,- gross per year (full-time); increased payment is possible. We are looking forward to your application.