Expert (m/f/x) CMO Quality Management

JR Germany; Pfaffenhofen an der Ilm; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der Pharmaindustrie sucht einen Experten für Qualitätsmanagement, der die Qualitätssicherung bei externen Herstellern überwacht. In dieser Rolle sind Sie verantwortlich für die Einhaltung internationaler GMP/GDP-Vorschriften und die Unterstützung bei der Entwicklung des Unternehmens-Qualitätsmanagementsystems. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um sicherzustellen, dass Produkte von höchster Qualität auf den Markt kommen. Wenn Sie eine Leidenschaft für Qualität und Compliance haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• Mindestens 3 Jahre relevante Erfahrung in der Pharmaindustrie.
• Mindestens 1 Jahr in Qualitätssicherung oder Qualitätsmanagement.

Aufgaben

• Verwalten der Qualitätsaufsicht bei CMOs und Sicherstellung der Einhaltung von GMP-Vorgaben.
• Unterstützen globaler Teams bei der Definition von Qualitätsanforderungen.

Kenntnisse

Qualitätsmanagement

GMP/GDP Vorschriften

Kommunikationsfähigkeiten

Teamarbeit

Englischkenntnisse

Deutschkenntnisse

Ausbildung

Bachelor in Natur- oder Pharmawissenschaften

Berufsausbildung in der Pharmaindustrie

Jobbeschreibung

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Posted:

08.05.2025

Expiry Date:

22.06.2025

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Job Description:

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

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

Expert (m/f/x) CMO Quality Management

Purpose of the role: You will support the primary contact for quality-related topics (CMO-MQ) at contract manufacturing organizations (CMOs). Your responsibilities include managing quality oversight at the CMOs, implementing and maintaining DS quality standards (GMP/GDP), and ensuring compliance with regulatory requirements for our oncology products. Additionally, you will support other DS functions in quality-related topics and processes.

• Manage quality oversight at CMOs:
• Support the responsible person for quality topics like change control, deviations, and complaints related to DS products at CMOs and independently handle assigned tasks.
• Track the timely implementation of CAPAs related to deviations or audit findings and verify their effectiveness in collaboration with the CMO and internal stakeholders.
• Review, evaluate, and approve documents such as complaint investigations, deviation reports, or change controls, involving relevant stakeholders as necessary.
• Ensure the CMO operates in compliance with established QAA and international GMP guidelines.
• Support CMO-MQs during Authority Inspections at different suppliers as needed.
• Collect and process data from CMOs according to internal SOPs.

Act as a global information distributor:

• Support global teams and SMEs to identify and define quality needs for CMOs.
• Share quality-related information from the CMOs with global stakeholders within the QA environment and during department meetings.

Participate in developing the corporate QM-System:

• Assist global teams in improving the DS quality system and SOP landscape.

This role involves working globally in close cooperation with departments such as Supply Chain, Tech Management, and Regulatory Affairs to ensure consistent supply of high-quality products to markets.

• Bachelor's degree in natural or pharmaceutical sciences with at least 3 years of relevant experience, or vocational training in the pharmaceutical industry with at least 6 years of relevant experience.
• At least 3 years of relevant work experience in the pharmaceutical industry, including:
• At least 1 year in Quality Assurance or Quality Management, preferably in Shop Floor QA or QA Oversight for Manufacturing.
• At least 2 years in a GxP environment involved in manufacturing or similar activities.
• Excellent knowledge of international GMP/GDP regulations.
• Assertiveness, strong communication skills, and a diplomatic attitude during negotiations.
• Team player with high quality consciousness and a solution-oriented mindset.
• Proficiency in English and German, both written and verbal.
• Experience managing CMOs or external suppliers is beneficial.
• Willingness to travel up to 10%, domestically and internationally.