For one of our clients in Basel we are looking for a Senior Clinical QA Manager.
- Do you have a degree in life sciences?
- Do you really enjoy working in cross functional teams?
- Do you have excellent oral and written communication skills in English?
Then you might be the candidate we are looking for! Don't hesitate to apply now!
• Work as per the defined strategy for the global clinical audit program (e.g. site, vendor, process)
• Plan, perform, and report audits (e.g. site, vendor, process) using considerable latitude in determining best practice and approach
• Develop own area of ICH-GCP expertise with limited supervision (e.g. self-training, knowledge acquisition by reading/assisting to course identify by himself)
• Lead the preparation, facilitation and follow up of inspections by national and international regulatory authorities
• Facilitate the CAPAs elaboration and follow-up
• Escalate serious / continuing non-compliance issues as appropriate
• Make a significant contribution to ensure that QS documents creation and management is done in accordance with ICH-GCP requirements / regulations
• Contribute to process improvements and trouble shooting
• Maintain awareness / expertise in international ICH-GCP requirements
• Provide leadership and direction on ICH-GCP related activities / issues
• Work closely with internal / CRO Clinical Trial Teams
• Support internal / CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical Quality Management System and clinical trial framework by different ways (e.g. provide training to CD staff, feedback to ICH-GCP questions)
• Highly contribute to develop/improve CQA tools and processes
• Represent CQA in internal and external meetings and particularly represent Team Leader CQA when he/she is not available
• Perform any other CQA task that could help to achieve a high adherence to ICH-GCP requirements
- Degree in (life) sciences or healthcare
- Experienced in Clinical Research & Development. At least 6 years of experience in pharmaceutical industry/health authority with at least 3 years of experience in Quality Assurance / Auditing (QA) within the ICH-GCP environment.
- In-depth knowledge of global ICH-GCP requirements and pharmaceutical industry practices
- Ability to work as a team player and independently
- Reliable, conscientious, agile/flexible
- Proven record of excellent problem solving, risk analysis and negotiation skills
- Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource)
- Experience in medical device and/or combination product will be an added value
- Strong writing, communication and listening skills
- Experience in international cross-cultural relations
- Very good English knowledge (written and spoken)
Ulrike De Smedt
+32 15 21 11 04