95 days ago on jobs.kellyservices.ch

Associate/ Director Vaccines Quality Assurance

Kelly Services (Schweiz) AG

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Associate/ Director Vaccines Quality Assurance


For our client, a renowned pharmaceutical company in Zurich we are hiring an
 
Associate/ Director Vaccines Quality Assurance
 
Major duties and responsibilities:

  • Ensures the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations
  • Responsible to develop and implement a strategic audit plan for a VBU vaccines development program.
  • Analyze audit program results, quality issues and investigations in order to optimize regional operations and overall regional state of compliance.
  • Ensure that activities are conducted and reports written according to applicable SOPs and regulations.
  • Oversees all GCP QA, PVQA, and GCLP QA activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity.
  • Identifies and mitigates GCP/PV/GCLP quality and compliance issues with potential impact across multiple compounds, sites, or functional groups within or outside of VBU
  • Collaborates with the R&D QA, and other global entities to provide a consistent quality approach, including:
    • Develops and presents periodic reports for assigned project describing VBU compliance trends and identifying areas of potential risk to VBU senior management.
  • Determines acceptability of vendors for potential use by VBU and provides direction, guidance and strategy for VBU Quality.
 
Education:
  • Bachelor or Master in Biology, Nursing, Pharmacy, or related scientific field. 
 
Experience:
  • Minimum of 10 years of increasing responsibility in pharmaceutical, GCP-related Quality environment.
  • Minimum 7 years indirect management level experience in GCP Quality Assurance  including senior level project planning/budget management
  • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred

 
Are you the person we are looking for? Then apply online today!
Ms. Daniela Ernst, PhD (Tel: +41 (0) 44 225 41 06) is open for further questions.         
 
Kelly Services (Schweiz) AG, Löwenstrasse 29, 8001 Zürich, Opening hours Mo - Fr 8h00 – 12h00 / 13h30 – 18h00