Senior Quality Assurance Auditor (m/w/d) | Frankfurt | JBA15121

Responsibilities

• 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

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

_____

Constaff GmbH - 100%OpenBook. Ehrlich. Kompetent. Transparent.

• 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

Project details

November 2026

12 months++

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

• Start: ab sofort
• Duration: 12 Monate
• Remote: hybrid
• Location: Frankfurt, Deutschland, DE
• Languages: English, German