Quality Assurance Manager GCP/PV/GLP

☞ Basilea Pharmaceutica International

View: 156

Update day: 26-03-2024

Location: Allschwil Basel-Landschaft BL

Category: Pharmaceutical / Chemical / Biotech

Industry:

Job type: Temps plein, CDI, Temps de travail : 90-100%

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Job content

We are looking for...
....a highly motivated Quality Assurance Manager GCP/PV/GLP for our Quality unit.
Your tasks
  • Implement and lead clinical Quality Assurance (QA) activities (GCP/PV/GLP) as assigned
  • Contribute to a risk-based strategy for QA activities (GCP/PV/GLP)
  • Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites
  • Act as contact person for vendors/investigator sites and manage deviations, quality issues, investigations, CAPAs, and change control related to GCP/PV/GLP
  • Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents
  • Provide advice and support for the audit process to ensure a good audit practice
  • Prepare and host regulatory inspections and partner GxP audits
  • Responsible for internal inspection readiness program and Health Authority inspections as assigned
  • Coordinate and lead internal or external training activities
  • Report critical issues to the Head of Global Quality Management assess their impact and propose risk mitigation as appropriate
  • Establish and manage work orders with external QA consultants and CROs
  • Budgeting and cost control of assigned tasks
  • Participate or lead departmental and cross-functional compliance initiatives
Your profile
  • Minimum 8 years of experience in the Pharmaceutical industry and a minimum of 5 years’ experience in QA GCP/GVP
  • University degree in pharmacy, chemistry, chemical engineering or equivalent, an auditor qualification would be an asset
  • Experience in auditing GCP and GMP
  • 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 and German written and spoken is essential, any other language would be beneficial
About us

Basilea is a revenue-generating, commercial-stage Swiss biopharmaceutical company. Our activities are focused in the areas of hospital antibiotics and hospital antifungals. Our portfolio comprises of two marketed anti-infective brands (Cresemba® and Zevtera®) and several preclinical anti-infective assets. We are building on our potential for sustainable growth and valuation generation, based on increasing revenues and selective investments into internal and external innovation. Basilea was founded in 2000 and is located in the life sciences hub of the Basel area. Basilea has about 150 employees. Since 2004, Basilea is listed on the SIX Swiss Stock Exchange with the ticker symbol BSLN.

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Deadline: 10-05-2024

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