• BioAgilytix Europe QA
  • Hamburg, DEU
  • Full Time

BioAgilytix Europe, an affiliate of BioAgilytix Labs, is a contract research organization (CRO) in Hamburg, Germany that offers fully integrated bioanalytical laboratory services to support every stage of biologics development from early discovery through pre-clinical studies and clinical phases I, II, III and IV including custom assay development and validation and sample analysis as well as drug release testing. As a GLP, GCP/GCLP and GMP bioanalytical lab facility, BioAgilytix Europe supports product releases of biologics, biosimilars, and biobetters.

The Position:

The employee will report to the VP Global QA, BioAgilytix Labs and the principal responsibilities are:

  • Managing the European Quality Management System (QMS), conducting periodic reviews of the QMS, and implementing CAPAs as required.
  • Planning, leading and organizing the European QA to sustain a comprehensive, efficient and effective compliance program/quality management system to satisfy regulatory and company requirements.
  • Overseeing/performing audits in a technical discipline to verify conformance to applicable SOPs, methods, protocols/plans and regulatory requirements.
  • Write or oversee generation of QA SOPs and provide regulatory input for other department SOPs and company policies.
  • Hosting Sponsor audits and Government Agency Inspections.
  • Generating responses to all site audit/inspection reports and performing follow-up with respondents, management, or others.
  • Analyzing and communicating assessment of significant compliance risk information to the Test Facility Management, VP Global QA and other Executive Management.

Position Requirements:

  • Requires a college degree in science and extensive knowledge of GLP or GCLP/GCP global regulations and industry standards.
  • Minimum of 8+ years working in a GLP or GCLP/GCP regulated environment with a minimum of 5 years of management experience.
  • Regulatory authority inspection experience, required
  • Experience in organizing and directing a cross-functional team to ensure compliance with applicable regulations for all compliance activities undertaken.
  • Excellent oral and written communication skills are essential.
  • Business travel will be a component of the position (travel minimally 25%).
  • Fluency in English is required.
  • Fluency in German is required.

Benefits /Future Perspectives:

  • International working environment
  • Attractive salary
  • Bonus program
  • Professional training opportunities
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