Manager Clinical Quality Assurance

Manager Clinical Quality Assurance

Octapharma

Vienna, Austria

Your new challenges which will inspire you:

  • Support continuous improvement at CR&D, identify compliance weaknesses and work with staff to identify possible root cause and develop effective corrective and preventive action plan;
  • Maintenance of the SOP system in CR&D (support development/updating of SOPs, manage approval process, SOP distribution and filing), ensure that processes described in SOPs are in compliance with applicable regulations;
  • Manage the CR&D training program (maintenance of training records, planning and performance of staff training, organize training sessions);
  • Ongoing quality support to CR&D staff and provide QA input to special projects in CR&D as necessary;
  • Perform QC review of clinical documents (study protocol, study report, master informed consent);
  • Support management of contractors (initial qualification, ongoing quality review, contractor audits);
  • Perform clinical study audits (e.g. at CRO, study site, central lab), including planning, performance, reporting and follow up open corrective and preventive actions until completion;
  • Assist in preparation, conduct and follow up of regulatory inspections;
  • Keep informed about most regulations and guidelines pertaining to GCP and clinical trial activities including EU and US regulations.

Your profile that will convince us:

  • University degree (preferably medical or biosciences);
  • At least 3 years’ experience in the Pharmaceutical or CRO Industry, preferably in Clinical Operations;
  • Experience in quality management desirable (certified quality manager and quality auditor);
  • Practical experience in clinical QA desirable;
  • Strong analytical, problem solving skills with excellent written and verbal communication skills;
  • Strong organizational, presentation, documentation and interpersonal skills;
  • Good clinical knowledge with an understanding of medical terminology;
  • Solid understanding of applicable guidelines and regulations for clinical studies;
  • Advanced level of computer literacy (MS office applications, understanding of databases, understanding of computerized systems validation requirements);
  • Excellent English;
  • Team oriented;
  • Willingness to travel (travel time up to 60%).

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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