Manager Clinical Quality Assurance (m/f/d)
Octapharma
Vienna, Austria
vor 1 Tg.

Octapharma specializes in the development of highly pure pharmaceuticals made of human blood

plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production

site, but also a successful research location of the Octapharma Group. Since our company continues

to grow, we are now hiring for our team a

Manager Clinical Quality Assurance (m / f / d)

Experienced

Research & Development

Fulltime

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 app. 30%)
  • Our attractive benefits for you :

  • Wide range of tasks in an international setting, flexibility and personal responsibility
  • Reliable employer with generous employee benefits and a salary customary in the market.
  • Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant,
  • extraordinary staff events and many more :

    Additional information :

    The minimum gross wage according to the collective agreement (chemical industry) for your new job

    is EUR 3.270,89. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.

    We are looking forward to new, committed employees who join forces with us to promote our strong

    growth in order to keep enabling our patients to live a better life - because it is in our blood! Is it in

    your blood too?

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