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Job Details

Head of Quality and Regulatory Affairs 100% (m/f) in Basel

Company: SciPro
Location: Basel
Reference: SPPO0901
Closing Date: 06 Feb 17
Type: Permanent
Salary (£): 80,000 - 100,000
Benefits:

Job Summary:

Head of Quality and Regulatory Affairs 100% (m/f) in Basel Our client is a start-up in vitro diagnostics company developing qualitative diagnostic tests for the detection and screening of various infectious diseases.Therefor we are looking for a constructive and solution-oriented personality as Head of Quality and Regulatory Affairs. Our client offer an attractive working environment combined with a supportive and understanding team for Quality. ...

Requirements:

Head of Quality and Regulatory Affairs 100% (m/f) in Basel



Our client is a start-up in vitro diagnostics company developing qualitative diagnostic tests for the detection and screening of various infectious diseases.

Therefor we are looking for a constructive and solution-oriented personality as Head of Quality and Regulatory Affairs. Our client offer an attractive working environment combined with a supportive and understanding team for Quality.

The jobholder will report directly to the CEO/CFO.

Responsibilities:



* Maintenance and performance monitoring of the Quality Management System
according to EN ISO 13485
* Responsible for risk management according to EN ISO 14971
* Quality planning (verification and validation)
* Addressing quality issues and implementing quality controls
to ensure continuous compliance
* Execution of audits (supplier audits)
* Initiation and monitoring of actions
* Organisation of Management Reviews and monitoring of resulting actions
* Process validation, QA and QC monitoring and product release
* Assuring communication with internal and external stakeholders
* Establishment of productive relationships with statutory and regulatory authorities



Qualifications:



* University Degree in Molecular Biology or similar education, preferably with Ph.D.
* Further education in Quality System Management
* At least 3 years of experience in Quality Management in IVD or Medical Device industry
* Additional experience in IVD product development and launch is strongly preferred
* In depth knowledge of EN ISO 13485 requirements and relevant international standards, regulations and directives
* Hands on experience in quality assurance
* Regulatory, legal and QC support and working closely with other stakeholders on different level
* A team player with assertiveness and strong communication skills who shows flexibility especially within a start-up company
* strong Analytical thinking
* strictly goal oriented as well as self-motivated
* High accuracy in management of data
* Fluent in English and German, spoken and in writing
* Willingness to travel worldwide



Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de



In case of any further question, please do not hesitate to contact
Petra Ognjenovic: 0049 89 2109 4906.

Apply for this job: Head of Quality and Regulatory Affairs 100% (m/f) in Basel

Contact Information:

Address:  Head Office
4th Floor, 150 Leadenhall Street, London
EC3V 4TE
England
Tel:  +44(0)203 327 3072
Website:  Visit Our Web Site

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