Merz Therapeutics

Senior Quality Assurance Manager GCP

Merz Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Frankfurt am Main • 🇩🇪 Germany

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Job Level

Senior

Tech Stack

Google Cloud PlatformTypeScript

About the role

  • Responsibility for quality assurance within the R&D departments at Merz Therapeutics
  • Development and maintenance of systems and tools to support quality processes
  • Quality management according to GCP and IT requirements (e.g., GAMP, 21 CFR Part 11)
  • Planning and conducting audits, including reporting and CAPA tracking
  • Support for quality- and IT-specific inquiries
  • Ensuring compliance in global clinical development projects
  • Preparation for and support during regulatory inspections
  • Conducting GCP training as needed

Requirements

  • Degree in a scientific discipline or equivalent qualification
  • At least 5 years' experience as a GCP auditor in quality assurance
  • Solid knowledge of GCP requirements for clinical drug development
  • Good knowledge of MS Office and quality management processes
  • Excellent communication skills, ability to work in a team, and a structured working style
  • High sense of responsibility, strong team spirit, and willingness to learn new skills
  • Fluent in English; German is an advantage
Benefits
  • Individual career development in a meaningful role: you help improve the quality of life for our patients!
  • Hybrid working model that enables a good work–life balance
  • Attractive location with good transport connections, modern workspaces, and a company canteen
  • Global family-owned company with flat hierarchies and an open, respectful corporate culture
  • Competitive compensation with comprehensive social benefits
  • A variety of employer-supported benefits such as WellPass, the DeutschlandTicket, Corporate Benefits and JobBike

Applicant Tracking System Keywords

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

Hard skills
GCP auditingquality assurancequality management processesCAPA trackingregulatory inspectionsclinical drug developmentGAMP21 CFR Part 11
Soft skills
excellent communication skillsteamworkstructured working stylehigh sense of responsibilitystrong team spiritwillingness to learn