(Senior) Quality Manager (m/f/x) CMO

ZipRecruiter; Pfaffenhofen an der Ilm; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der Pharmaindustrie sucht einen (Senior) Qualitätsmanager, der für die Qualitätssicherung bei Vertragsherstellern verantwortlich ist. In dieser spannenden Rolle sind Sie der Hauptansprechpartner für alle qualitätsbezogenen Themen und arbeiten eng mit verschiedenen Abteilungen zusammen, um sicherzustellen, dass die Produkte den hohen Qualitätsstandards entsprechen. Sie bringen Ihre Expertise in der Qualitätsüberwachung, Verhandlungsführung und Teamarbeit ein, um die Qualität unserer Produkte zu gewährleisten. Wenn Sie eine Leidenschaft für Qualität und Teamarbeit haben, könnte dies die perfekte Gelegenheit für Sie sein.

Leistungen

Work-Life-Benefits

Wachstums- und Entwicklungsmöglichkeiten

Gesundheits- und Wellnessunterstützung

Qualifikationen

• Mindestens fünf Jahre relevante Berufserfahrung in der Pharmaindustrie.
• Ausgezeichnete Kenntnisse internationaler GMP/GDP-Vorschriften.

Aufgaben

• Verantwortlich für die Qualitätsüberwachung bei CMOs und die Einhaltung von Standards.
• Unterstützung bei Inspektionen und Audits sowie Identifizierung von Qualitätsrisiken.

Kenntnisse

Qualitätsmanagement

Kommunikationsfähigkeiten

Verhandlungsführung

Teamarbeit

Projektmanagement

Ausbildung

Masterabschluss in Natur- oder Pharmawissenschaften

Tools

GMP/GDP Vorschriften

Jobbeschreibung

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 our site in Pfaffenhofen/Ilm we are seeking qualified candidates to fill the position:

(Senior) Quality Manager (m/f/x) CMO

Purpose of the function:

In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs) involved in the manufacturing of small molecules. You manage the quality oversight at the assigned CMO/manufacturing site, which include implementation and maintaining of Daiichi-Sankyo quality standards (GMP/GDP) as described per quality agreements and international regulatory requirements. Furthermore, you support other DS functions as an expert in quality related topics and processes and support the global organization in product oversight.

• Manage quality oversight at CMO/manufacturing site, including
• Handling of quality related topics like change control, deviations and/or complaints related to manufacturing of DS products at CMOs
• Definition of effective CAPAs together with the CMO and tracking of the timely implementation
• Review, evaluation and approval of documents like APQRs, PPQ reports or CPVs
• Preparation and negotiation of QAAs with CMOs and ensure that the CMOs work in accordance with DS QAAs
• Support CMOs during Authority Inspections and audits on behalf of DS at different suppliers
• Identification of quality risks at our CMOs and escalation of issues in case it becomes necessary
• Act as information distributor within QA and to other departments
• In your new role you support local and global teams and SMEs to identify and define quality needs for CMOs
• You share quality related information from the CMOs to our regional and global stakeholders within the QA environment as well as in department overarching meetings
• You distribute information from stakeholders with the CMO and ensure timely implementation of agreed requirements
• Act as support for global and regional QA functions
• In global working teams you act as SME to improve the DS quality system and global SOP landscape
• Support regional QA functions for regulatory requests regarding e.g. GMP clearance or import license
• Share knowledge and expertise within QA or other functions to improvement CMO management at DS

In this role you will work regionally and globally in close cooperation with other departments like Supply Chain, CMC, regulatory functions and others to ensure consistent supply to markets with products which meet our high quality standards at any time.

• University/FH/Master degree in natural or pharmaceutical sciences
• At least five years of relevant work experience in the pharmaceutical industry and at least two of the four years in Quality Assurance and/or Quality Management
• Excellent knowledge of international GMP/GDP regulations
• Expertise in small molecule manufacturing for Drug Substance and Drug Product
• Have assertiveness, strong communication skill paired with diplomatic attitude during negotiations
• A true team player, high quality consciousness and a solution-oriented mindset
• Very good written and verbal communication skills in English and German
• Experience with managing CMOs or external suppliers is beneficial
• Project management skills is a plus
• Willingness to travel (up to 10%, domestic and international)

Excellent Benefits

• Work-Life Benefits
• Growth and Development
• Health and Wellbeing Support