Project Manager GMP & Quality Operations (m/f/d) Global Quality Operations

Merz Therapeutics GmbH; Frankfurt; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Hybrid work

WellPass

Deutschland-Ticket

Corporate Benefits

JobBike

Company restaurant

Zusammenfassung

Merz Therapeutics seeks a Project Manager GMP & Quality Operations (m/f/d) to lead cross-functional projects in Global Quality Operations. You will ensure GMP-relevant initiatives meet quality requirements, timelines, and budgets, acting as central coordinator with internal and external stakeholders.

This fixed-term role spans 24 months. Your responsibilities include setting up a new GMP laboratory, managing equipment transfers, and driving qualification activities.

Qualifikationen

• PM experience in pharmaceutical industry
• Experience with GMP-regulated infrastructure, lab, qualification or transfer projects
• Knowledge of GMP/GDP, quality systems, change control, qualification, validation

Aufgaben

• Manage cross-functional quality and compliance projects within timelines, budgets, and targets
• Coordinate setup of a new GMP laboratory including infrastructure and equipment
• Drive equipment transfer, qualification and requalification activities with stakeholders
• Coordinate internal and external stakeholders including suppliers and contract manufacturers
• Support change control activities and risk assessments related to quality and patient safety
• Coordinate implementation of regulatory packaging material requirements and monitor progress
• Maintain project plans, risk assessments, and audit-ready documentation
• Support process implementation and handover to operational quality teams

Kenntnisse

Project management

GMP knowledge

Quality systems

Change control

Stakeholder management

Analytical thinking

English fluent

Ausbildung

Degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering

Jobbeschreibung

YOUR CONTRIBUTION

As Project Manager GMP & Quality Operations (m/f/d), you will play a key role in driving complex cross-functional projects within Global Quality Operations. You will ensure that strategic, GMP-relevant, and compliance-critical initiatives are delivered on time, within budget, and according to quality requirements. Acting as a central coordinator, you will collaborate with internal and external stakeholders to successfully implement infrastructure, quality, and process improvement projects. This position is offered as a fixed-term contract for 24 months.

Your responsibilities will include the following tasks:

• Manage cross-functional quality and compliance projects, ensuring timelines, budgets, and quality targets are met
• Coordinate the setup of a new GMP laboratory, including infrastructure, equipment, and technical facilities
• Drive equipment transfer, qualification, and requalification activities with key stakeholders
• Coordinate internal and external stakeholders, including suppliers, service providers, and contract manufacturers
• Support change control activities and risk assessments related to quality, compliance, and patient safety
• Coordinate quality-related implementation of new regulatory packaging material requirements and monitor progress
• Maintain project plans, risk assessments, status reports, and audit-ready documentation
• Support process implementation and ensure effective handover to operational quality teams

YOUR PROFILE

• Degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, or a related scientific field
• Min. 5 years of experience in the pharmaceutical industry, ideally in Quality, Operations, or Project Management
• Experience managing GMP-regulated infrastructure, laboratory, qualification, or equipment transfer projects
• Strong knowledge of GMP/GDP requirements, quality systems, change control, qualification, and validation
• Excellent project management skills; PMI, PRINCE2, or similar certification is an advantage
• Strong analytical thinking and ability to manage complex technical and regulatory topics
• Excellent communication, stakeholder management, and organizational skills with a hands-on mindset
• Business fluent in English; German language skills are a plus

YOUR BENEFITS

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

Find out more about our benefits here.

ABOUT US

Welcome to Merz Therapeutics, a global leader in specialty neurology, delivering innovative treatments that help people with movement disorders, neurodegenerative conditions, liver disease, and other serious health challenges regain their quality of life.

We are proud to be a family-owned company with over 117 years of heritage. Our therapies reach patients in more than 80 countries, driven by a passion for innovation and a commitment to growth.

Our goal is to address urgent, unmet medical needs—investing in research, expanding our portfolio, and empowering people to live better lives.

Join our international Merz Therapeutics family and help us achieve our mission:

\"BETTER OUTCOMES FOR MORE PATIENTS\"