Senior Quality Assurance Auditor (m/w/d) | Frankfurt | JBA15121
Constaff GmbH
Ansprechpartner: Julia Barth
Frankfurt, Deutschland
Beschreibung
Start: November 2026
Duration: 12 months++
Location: Frankfurt
Project ID: 15121
Deadline: November 9, 2026
Dear Network,
For our client in Frankfurt we are looking for a Senior Quality Assurance Auditor (m/w/d).
https://www.constaff.com/projektbeschreibung/?positionID=15121
Tasks:
- Plan, conduct, document, and close audits to ensure compliance with regulatory requirements, customer requirements, and internal quality standards
- Evaluate audit findings and prepare and communicate audit reports
- Advise project teams, customers, and monitors on regulatory requirements, compliance matters, and audit findings
- Review and approve investigations, Root Cause Analyses (RCA), Corrective and Preventive Actions (CAPA), and Effectiveness Checks (EC)
- Track quality actions through to closure and manage quality-related events
- Conduct pre-inspection visits at clinical trial sites
- Review and improve policies, procedures, and quality processes
- Maintain the electronic Quality Management System (eQMS) and support the audit lifecycle
- Lead and contribute to Quality Assurance initiatives and process improvement projects
- Support training activities and the preparation and conduct of audits and regulatory inspections
- Deliver Quality Assurance consulting services and client projects within agreed budgets and timelines
Requirements:
- Bachelor's degree preferred.
- Several years of professional experience in the pharmaceutical, technical, or a related industry
- Experience in Quality Assurance Audits and relevant GCP knowledge, or an equivalent combination of education, training, and experience
- Experience conducting GCP audits at clinical trial investigator sites (Investigator Site Audits)
- Extensive knowledge of pharmaceutical development processes, regulatory requirements, and Quality Assurance processes
- Strong communication, interpersonal, and teamwork skills, with the ability to collaborate effectively with various stakeholders
- Excellent problem-solving, risk analysis, and negotiation skills
- Ability to work independently and in a structured manner, deliver training, and manage multiple projects simultaneously
- Proficiency in word-processing, spreadsheet, and database applications
- Willingness to travel 30–50% of the time, mainly within Europe
- Experience auditing Clinical Study Reports (CSRs), Trial Master Files (TMFs), and clinical trial data management is an advantage
- Fluent in English and good knowledge of German
Based on customer specifications, a project-related employment is aimed for
Are you currently interested and available?
Then please feel free to contact us anytime.
Contact:
Julia Barth
Expert Candidate Relations
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