Senior Quality Manager CMO (m/f/x)

TN Germany; Pfaffenhofen an der Ilm; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Germany is seeking a Senior Quality Manager to oversee quality at Contract Manufacturing Organizations (CMOs). The role involves managing quality topics, supporting global QA functions, and ensuring compliance with regulations. Join a culture of mutual respect and continuous learning to make a difference in patients' lives.

Qualifikationen

• Experience managing quality oversight at CMOs.
• Ability to define effective CAPAs and track implementation.

Aufgaben

• Manage quality oversight at CMOs, ensuring compliance.
• Support global teams to identify and define quality needs.

Kenntnisse

Quality Management

Regulatory Compliance

Change Control

Ausbildung

Degree in Life Sciences

Jobbeschreibung

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Job Reference:

540eb5a0ba8e

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Expiry Date:

25.06.2025

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Job Description:

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For Daiichi Sankyo Europe GmbH, we are seeking highly qualified candidates to fill the position:

Senior Quality Manager CMO (m/f/x)

Purpose of the role:

Roles and responsibilities:

1. Manage quality oversight at CMOs. You will be responsible for quality topics such as change control, deviations, and complaints related to manufacturing of DS products at CMOs. Define effective CAPAs with the CMO and track their implementation. Review, evaluate, and approve documents like APQRs, PPQ reports, or CPVs. Prepare and negotiate QAAs with CMOs, ensuring compliance. Support CMOs during Authority Inspections and perform audits. Identify quality risks and escalate issues as necessary.
2. Act as a global information distributor within QA and to other departments. Support global teams and SMEs to identify and define quality needs for CMOs. Share quality information with global stakeholders and ensure timely implementation of requirements.
3. Support global and regional QA functions. Act as SME to improve DS quality systems and SOPs. Support regional QA for regulatory requests. Share knowledge to improve CMO management at DS.

This role involves working globally, collaborating with departments like Supply Chain, CMC, and regulatory functions to ensure consistent supply of high-quality products to markets.

Why work with us?

Working at Daiichi Sankyo is more than just a job – it's an opportunity to make a difference and improve patients’ lives. We foster a culture of mutual respect, continuous learning, inclusion, and diversity. Here, you can grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for patient needs, we look forward to your application.