The Bernhard Nocht Institute for Tropical Medicine (www.bnitm.de) is the largest Research Institute for Tropical Medicine in Germany and is the National Reference Centre for Tropical Pathogens, a WHO Collaborating Centre and member of the Leibniz Research Association.
 
The Department of Virology at the Bernhard Nocht Institute for Tropical Medicine in Hamburg invites applicants for a full time position starting as of 1st May 2021 or later for the role of:
 

Quality assurance manager: laboratory (m/f/d)


The Virology Department of the BNITM is focused on tropical hemorrhagic fevers. Our Department provides laboratory support in Germany and abroad (mainly Africa) to clinical studies. We are looking for a highly motivated person to join our team to further develop and implement a Quality Assurance Management System for laboratory procedures in clinical studies in which we are involved.
 

Key Responsibilities:

  • Develop and implement a Quality Assurance Management System for laboratory procedures within clinical studies
  • Initiate and lead process improvements initiatives to enhance the efficiency and the quality of the work performed in the laboratory
  • Develop, review, distribute standard operating procedures (SOP), regulatory documents and laboratory protocols and manuals, or laboratory analytical plans as per project need
  • Develop and Manage robust training system for all laboratory staff on new/revised SOPs, GCP principles and applicable regulatory requirements
  • Coordinate and support training activities on new versions of controlled documents
  • Maintain compliance with Good Clinical Practice (GCP/GCLP), all relevant SOPS and applicable regulatory requirements
  • Coordinate and support process for issues identification, root cause analysis, issue resolution and CAPA management
  • Analyze trends and recommend process improvements
  • Schedule and oversee the conduct and reporting of internal and external audits conduct; host client/sponsor audits;
  • Work in close collaboration with internal team members as well as with external collaborators (sponsor, CRO, investigational sites representatives)

Qualification and Experience:

Required:
  • Minimum of Bachelor’s degree in Biology, Life-Science, Quality Management or equivalent studies
  • Minimum of 2 years experience in a laboratory environment and work experience in laboratory quality management oversight
  • Comprehensive knowledge of Quality Management Systems implementation and improvement
  • ICH-GCP and GCLP body of knowledge, as well as experience in the conduct of clinical trials
  • Excellent verbal and written skills in German and English are required
Desirable:
  • Experience performing or supporting GCP, GCLP, GLP audits
  • Experience preparing for and participating in regulatory inspections
  • Certification
  Skills & Competencies:
  • Ability to work with moderate supervision
  • Excellent organizational and time management skills
  • Team spirit and ability to work and communicate effectively in a multi-disciplinary team
  • Strong critical thinking skills to analyze and discern critical issues and non-compliant situations
  • Ability to analyze complex situations and recommend appropriate corrective and preventive actions

We offer:

  • An interesting and challenging job in a modern research institution
  • Possibility to work partly from home
  • A central location at the Landungsbrücken, easily accessible by public transport
  • 30 days of vacation per year
  • Flexible and family-friendly working hours
  • Subsidy for childcare
  • Subsidy for the HVV-ProfiTicket
  • Company pension scheme
  • Opportunities for further education and training
  • Special conditions in selected sports and fitness clubs in Hamburg
The position is limited until 31.12.2022 and is remunerated in accordance with the German salary scheme for the public service (TV-AVH Hamburg).


audit berufundfamilie - Zertifikat



We support our employees in achieving a work-life balance and promote the professional equality of women and men. We strive to assist women in their scientific career, increase the number of women in research and reduce under-representation in all areas and positions in general. Applicants with disabilities will be given preference when equally qualified.


 

Please send your application by 30.04.2021 via our job portal with the required documents (cover letter, CV, high school and university certificates with grades, if applicable references).
Alternatively you may apply by postal mail referring to "QAM-VIRO" to: Bernhard-Nocht-Institut für Tropenmedizin, Human Resources Department, Bernhard-Nocht-Str. 74, 20359 Hamburg.

If you have questions about the application/selection process, please contact Ms. Linda Dvorak (dvorak@bnitm.de).
For further questions please contact Dr. Sophie Duraffour (duraffour@bnitm.de, +49 40 42818-932), Department of Virology.