Quality Assurance Manager GCP

We are looking for...:
....a highly motivated Quality Assurance Manager GCP for our Quality unit.

Your tasks:
• Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites for assigned studies/ compounds
• Act as QA contact person for vendors/investigator sites for related GCP/PV/GLP studies
• Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents
• Contribute to a risk-based strategy for QA activities (GCP/PV/GLP)
• Ensure timely and appropriate management of non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control
• Support inspection readiness of Basilea and Vendors conducting GCP, PV, and GLP activities through review audit findings, CAPA generation and review, and training
• Support preparation, conduct and follow up of audits and inspections at client sites and partners as required
• Ensure audit results are formally tracked, recorded and reported
• Coordinate and lead internal or external training activities
• Willingness to travel for audits

Your profile:
• University degree in pharmacy, chemistry or equivalent, an auditor qualification would be an asset
• Minimum 10 years of experience in the Pharmaceutical industry and a minimum of 5 years’ experience in QA GCP
• Excellent knowledge of GCP and PV legislation and experience in auditing GCP, PV and GLP
• Experience in GCP/GVP related Health Authority Inspections (FDA, BfArM) 
• Familiar with writing/reviewing sections of regulatory documents (IMPDs, INDs)
• Ability to work both independently and collaboratively, well-organized and structured with excellent technical and analytical skills 
• Excellent communication and presentation skills at different levels
• Fluency in English written and spoken is essential, any other language would be beneficial

Why us?:
Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success. 
If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application. 
Additional information can be found on our website www.basilea.com.