Our client, a big pharmaceutical company based in Basel, Switzerland is looking for a Quality Leader 50%.
- To provide Global Product Development Medical Affairs (PDMA) staff with compliance support to ensure that all medical affairs activities are conducted in accordance to the Roche SOPs, guidelines and policies and all international (ICH, GCP) & Health Authority regulations
- To provide Quality Management support to PDMA and the Affiliates, and deliver a quality oversight plan andmetrics ensuring that Medical Affairs activities are executed efficiently, effectively and in compliance with regulations
- To support the sharing of ‘best practice’ learnings within PDMA and the Medical Network
- Ensure PDMA staff are trained on Roche Controlled Documents and international regulations (ICH GCP) or Health Authorities requirements
- Co-ordinate the Learning Management system for PDMA and maintain PDMA Training Grid for Controlled Documents for relevant functions and external vendors
- Support the functional induction and orientation program for new PDMA staff
- Implement Quality Management processes to improve the accuracy or timelines of its output, or to meet established standards (e.g. compliance checks)
- Develop and maintain PDMA quality standards & metrics for key medical affairs activities
- Active review of audit reports, propose and monitor action plans (CAPAs) to improve medical affairs standards & processes
- Member of Quality networks
- Inspection Readiness support for PDMA
- At least 6 years professional experience within the pharmaceutical industry, preferably in a medical affairs function at a local, regional or global level
- In-depth knowledge of ICH, GCP, SOPs and regulatory requirements
- Experience in Quality Risk Management or Quality Management is an advantage
- Strong analytical and decision making skills in a complex, fast paced, and changing environment
- Experience of resolving complex issues in a matrix organization
- Appreciates the diversity of working across multiple cultures and countries
- Pharmaceutical industry knowledge and understanding/experience with drug discovery & commercialization processes
- In-depth knowledge of Clinical Trial Methodology, ICH, GCP, SOPs and regulatory requirements
- Fluency in written and verbal English language
If you match the above skill set I look forward to receiving your application, including a motivational letter, via this website.
Please check that your qualifications and experience match the vacancy and that you fill the required criteria. After you have submitted this application form with a current CV, we will endeavour to contact you as soon as we can.
Please submit your CV in Microsoft Word format. We are unable to accept CVs submitted in alternative formats.
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