Hobson Prior are looking for a QA Manager to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients.
This position is on a contract basis, located in Basel.
Job Responsibilities :
Accountable to 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.
Facilitate the CAPAs elaboration and follow-up.
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.
Raise any serious / continuing non-compliance issues as appropriate.
Contribute to process improvements and trouble shooting.
You will support the organisation / CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical.
Make a significant contribution to ensure that QS documents creation and management is done in accordance with ICH-GCP requirements / regulations.
Maintain awareness / expertise in international ICH-GCP requirements.
Deliver leadership and direction on ICH-GCP related activities / issues.
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 / imoliprove CQA tools and processes.
Represent CQA in internal and external meetings and particularly represent Team Leader CQA when he / she is not available.
Key Skills :
Excellent English knowledge (written and spoken).
Strong writing, communication and listening skills.
Proven record of excellent problem solving, risk analysis and negotiation skills
Ability to work as a team player and independently.
Reliable, conscientious, agile / flexible.
Bachelor degree or equivalent education / 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 within the ICH-GCP environment.
Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource).
In-depth knowledge of global ICH-GCP requirements and pharmaceutical industry practices.
Previous experience in medical device and / or combination product will be an added value.
Previous experience in international cross-cultural relations.
Apply now :
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV.
Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
Hobson Prior is acting as an Employment Agency in relation to this vacancy.