Tubulis GmbH

Manager QA GCP/GLP

Tubulis GmbH

full-time

Posted on:

Location Type: Remote

Location: Germany

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Tech Stack

Google Cloud Platform

About the role

  • Create and maintain global GCP audit programs in collaboration with the Director QA-GCP.
  • Manage the vendor qualification program of assigned vendors.
  • Manage (planning, execution, and delivery) and/or oversee audit activities in the GCP area for all phases of clinical studies, suppliers, systems, and documents to assess compliance with Tubulis SOPs and applicable regulations and guidelines (e.g. ICH, CTR, US FDA, and National regulations), identifying compliance issues, communicating results to and educating auditees, project teams, and management.
  • Manage audit activities (planning, execution, and delivery) for GLP vendors and review and approve GLP quality documentation provided by vendor.
  • As subject matter expert provide GxP expertise (interpretation and guidance), in collaboration with relevant internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities and provide input for mitigation activities.
  • Represent QA in internal meetings, e.g. in Tubulis Trial Team meetings, as assigned.
  • Act as QA counterpart to GCP/GLP vendors to address and resolve any quality issues.
  • Support regulatory inspections (preparation, hosting, follow-up), as requested.
  • Support Director QA GCP in development and maintenance of quality management systems (QMS) in the area of GCP/GLP.

Requirements

  • BS/MS in Life Science field or medical field.
  • At least 5 years of experience of QA GCP in biotech.
  • Experience in auditing GCP vendors including full service CROs, laboratories and clinical trial sites.
  • Experience in auditing and/or overseeing audits of GLP vendors.
  • English fluent, written and spoken.
  • Very good knowledge of international GCP and GLP regulations and guidance (EU, MHRA, and FDA regulations), or willingness to get into GLP QA area.
Benefits
  • Impact that matters : Contribute to breakthrough therapies.
  • Global mindset : Work in an international, diverse team.
  • Grow & thrive : Develop your career in a supportive, fast-moving environment.
  • Innovation every day : Push boundaries with cutting-edge science.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GCP auditingGLP auditingquality management systemscompliance assessmentrisk assessmentquality documentation reviewregulatory inspection supportvendor qualification managementclinical study oversightSOP compliance
Soft Skills
communicationcollaborationproblem-solvingeducational skillsleadershiporganizational skillsattention to detailinterpersonal skillsproject managementsubject matter expertise