(Senior) Quality Assurance Manager GCP (m/f/d)

Merz Therapeutics; Frankfurt; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Frankfurt is seeking a (Senior) Quality Assurance Manager GCP to oversee quality assurance in R&D. The candidate will manage quality processes, ensure compliance with GCP standards, and conduct audits. Required are a scientific degree, 5+ years in GCP auditing, and proficiency in English. The role offers a hybrid work model, competitive salary, and career development opportunities.

Leistungen

Hybrid work model

Attractive location with good transport links

Career development opportunities

Extensive social benefits

Employer-subsidized benefits like JobBike

Qualifikationen

• Min. 5 years of experience as a GCP auditor in quality management.
• Sound knowledge of GCP requirements for clinical drug development.
• Excellent communication skills.

Aufgaben

• Development and maintenance of quality assurance systems and tools.
• Planning and execution of audits and CAPA follow-up.
• Ensure compliance in global clinical development projects.

Kenntnisse

GCP auditing

Quality management

German language skills

MS Office proficiency

Team collaboration

Structured work approach

Ausbildung

Completed scientific degree or equivalent training

Jobbeschreibung

YOUR CONTRIBUTION

As a (Senior) Quality Assurance Manager GCP (m/f/d), you will be responsible for quality assurance within the R&D departments at Merz Therapeutics, in accordance with applicable regulations – including requirements for IT systems used in clinical trials. This is a full-time position, and your key responsibilities will include:

• Development and maintenance of systems and tools supporting quality processes
• Quality management in accordance with GCP and IT regulations (e.g., GAMP, 21 CFR Part 11)
• Planning and execution of audits, including reporting and CAPA follow-up
• Support with quality-related and IT-specific inquiries
• Ensuring compliance in global clinical development projects
• Preparation for and support during regulatory inspections
• Delivery of GCP training sessions as needed

YOUR PROFILE

• Completed scientific degree or equivalent training
• Min. 5 years of experience as a GCP auditor in quality management/ within quality assurance
• Sound knowledge of GCP requirements for the clinical development of drugs
• Good knowledge of MS Office, quality management processes
• Excellent communication skills, ability to work in a team, and a structured approach to work
• High level of responsibility, Strong team spirit and interest in acquiring new skills
• Business fluent in English, German is an advantage

YOUR BENEFITS

• Individual career development in a purposeful job: you improve the quality of life of our patients!
• Hybrid work model that allows a good work-life balance
• Attractive location with good transport links, modern workplaces and a company restaurant
• Global family business with flat hierarchies and an open, respectful corporate culture
• Attractive remuneration with extensive social benefits
• Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike

ABOUT US

Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.

We are proudto be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.

Our goalis to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.

Our dedication and commitmentto relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.

Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal:"BETTER OUTCOMES FOR MORE PATIENTS"