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Quality Assurance Manager GCP (m/f/d)

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort

 

To support their expanding Quality Assurance Team we are looking for a:

Quality Assurance Manager GCP (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    München

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    26658

  • Aktualisierung:

    2021-09-01

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Your tasks

  • Plan, prepare and conduct (external) audits (investigator sites, vendors, processes, systems, documents etc.)
  • Plan, prepare and conduct internal (GCP) audits
  • Write audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventive action plans
  • Ensure the timely and effective follow up of all identified or assigned quality issues
  • Conduct QA review of study protocols, ICFs, CSRs and other clinical trial specific documents as requested
  • Provide help, advice and guidance to operational departments on matters of quality/GCP
  • Coordinate, conduct and track GCP training of new and existing staff;
  • Create, maintain and revise departmental Quality Documents (SOPs, WIs, Forms etc.)
  • Management of Quality Documents according to the respective written procedures
  • Provide support/participate in authority inspections
  • Maintain required knowledge of applicable regulations, guidelines and company standards and procedures
  • Support the Director Quality Assurance GCP

Your qualifications

  • Academic degree in a scientific, medical or related field
  • Minimum of 3+ years’ current work experience in biotech/pharmaceutical industry Quality Assurance
  • Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
  • Profound knowledge of current GCP regulations and best practices, as well as experience in FDA and EMA inspections
  • Experience with global late-stage clinical trials leading to market authorization
  • Demonstrated Issue Management and CAPA experience in a clinical environment
  • Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
  • Excellent written/oral communication skills in English and German and interpersonal skills
  • Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents
  • Self-starter and team-player
  • Knowledge in Microsoft Office applications, Adobe
  • Experienced in working with EDC, IRT, eTMF, EMR systems
  • Willingness to travel (national and international)

Your contact person

Rosalin Temin
Recruitment Assistant

Phone:
+49 441 21879-20
Email:
rosalin.temin@optares.de

Address

Optares GmbH & Co. KG
Rosalin Temin
Cloppenburger Straße 9
26135 Oldenburg