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Senior Manager Quality Assurance GCP (m/f/d) (DE)

[5842]

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 our team we are looking for a Senior Manager Quality Assurance GCP (m/w/d) Your tasks ·Plan, prepare and conduct external and internal (GCP) audits (investigator sites, vendors, processes, systems, documents etc.) ·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 ·Evolve the current Quality Management System together with the QA team ·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 Your qualifications ·Academic degree in a scientific, medical or related field ·Ideally 3+ years’ current work experience in biotech/pharmaceutical industry Quality Assurance ·Demonstrated Quality Management System experience (GCP specific QMS experience preferred) ·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) ·Possibility of mobile working after consultation with the supervisor For further questions, please contact Mr. Tilman Grumbd at +49 441 21879-34 or via e-mail at tilman.grumbd@optares.de.

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 our team we are looking for a

Senior Manager Quality Assurance GCP (m/w/d)

Your tasks

  • Plan, prepare and conduct external and internal (GCP) audits (investigator sites, vendors, processes, systems, documents etc.)
  • 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
  • Evolve the current Quality Management System together with the QA team
  • 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

Your qualifications

  • Academic degree in a scientific, medical or related field
  • Ideally 3+ years’ current work experience in biotech/pharmaceutical industry Quality Assurance
  • Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
  • 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)
  • Possibility of mobile working after consultation with the supervisor

For further questions, please contact Mr. Tilman Grumbd at +49 441 21879-34 or via e-mail at tilman.grumbd@optares.de. 

map München, Deutschland date_range 28.11.2022 update Permanent
Medical Qualitätswesen
Direct contact

Tilman Grumbd

Geschäftsführer
mail tilman.grumbd@optares.de
phone +49 441 21879-34


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