QA-Manager (m/f)

Vor Ort
12 MM++
Hays AG
in Hesse
flag_no Deutschland

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Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.

We are looking for a
QA-Manager (m/f)

Referenz: 124532/1-en
Beginn: asap
Dauer: 12 MM++
Ort: in Hesse
Branche: Forschung und Entwicklung im Bereich Biotechnologie

Ihre Aufgaben:
  • Ensure that QA audits of clinical trial data are conducted in order to assure compliance with SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements
  • Coordinate the QA function for other offices as agreed
  • Manage the allocation of workload and supervision of auditors in the relevant office
  • Train QA auditors and assist in training other staff regarding GCP, ISO 9000, role of QA and regulatory audits etc, as required
  • Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively
  • Ensure that relevant new contracts / cost proposals are reviewed in order to enable the preparation of audit plans
  • Proactively develop and maintain the quality systems and procedures, in line with changes in laws, standards and regulations and to ensure process improvements
  • Perform the QA review on SOPs when designated this responsibility
  • Liaise with clients and project managers on quality aspects of studies including the attendance at marketing meetings, project meetings, oral presentations and audits
  • Assist with the preparation of the local department budget and ensure effective cost control
  • Keep the person to whom the QA Manager reports informed of any QA issues within the department/office that require attention

Ihre Qualifikation
  • Background in medicine, science and/or other relevant discipline and appropriate experience, such as Good Clinical Practice
  • Extensive experience in Quality Assurance auditing some of which should have included management/supervisor responsibilities
  • People management skills, including the ability to supervise, train and develop staff and to delegate effectively
  • Change management skills and the ability to secure staff commitment to change
  • In depth knowledge and understanding of drug development and the clinical trial process
  • Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients
  • Team building and leadership skills
  • Cost consciousness, with good commercial awareness and customer focus
  • Ability and willingness to travel at least 35% of the time (international and domestic)

- Quality Manager Pharma