Director Global Medical Support Quality Job in Bern, Switzerland

Our clients in the regions of Bern, Basel, Zurich and Lausanne are looking for executives and specialists from the following sectors:

- Biotechnology / pharmaceutical industry
- Telecommunications / telematics
- Computer science, new media
- High Tech Industries
- Business management

Director Global Medical Support Quality Job Description

Are you looking for a challenge in your professional career? Are you a team player with focus on Medical Quality Support and GMP?

Our customer CSL Behring AG is a subsidiary of the Australian company CSL Limited, a pharmaceutical company which is active worldwide. The site in Bern employs over 1’000 people in the development, production and sales of therapies derived from human plasma. For the Global Quality Management Group we are seeking an experienced, communicative and pragmatic personality (f/m) as

Director Global Medical Support Quality

The position contributes to development, production and marketing of safe and efficacious CSL Behring healthcare products, providing, as appropriate, medical expertise and assessments to CSL Behring and CSL Plasma Quality organizations in Bern, Kankakee, Marburg, Broadmeadows, and Boca Raton.

Your main tasks are:

• Assess a prospective impact of unexpected deviations from specified quality during manufacture or during release testing of a product on the safety and efficacy of the product in patients within its labeled use using medical, pharmacological, toxicological, pharmaceutical and chemical considerations, as appropriate.
• Aid the business units responsible for product quality/product release in making appropriate qualified decisions relating to the disposition of the concerned intermediate or product.
• Assess a prospective impact of unexpected deviations from the specified or usual quality of the starting material on safety and efficacy of the product manufactured from the concerned material.
• Perform simple toxicological evaluations for requests such as, e.g. evaluation of data from leachable / extractable studies or other, as appropriate, based on literature available in freely accessible databases.
• Perform medical review of Product Technical Complaints, as needed, according to product trends and types of complaints and provide feedback to Quality.
• Support site company physician/nurse in providing to the staff of CSL Behring in Bern emergency medical services during working hours.

Director Global Medical Support Quality Job Requirements

Your qualifications:

• Medical Doctor with more than 6 years of professional experience in practical medicine, pharmaceutical medicine and pharmacology.
• Familiar with basic toxicology, biotechnology or plasma products is an advantage.
• Strong commitment to quality of products, processes and systems.
• Strong internal and external customer focus especially on patient's safety. Ability to build productive relationships to understand and meet the needs of customers.
• Must be responsive to urgent customer requests.
• Ability to work individually and in a team with good flexibility and focus on priorities.
• Familiarity with literature search strategies.
• Ability to evaluate, judge and draw conclusions from literature publications.
• Excellent command of English, preferably good command of German.
• Possess good computer literacy in MS Office skills.
• Willingness to undertake some international travel (up to 10%)

Director Global Medical Support Quality Application Information

Please apply with your CV and cover letter by the 'apply' button below

Director Global Medical Support Quality Summary

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