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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Senior Quality Manager CMOAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich,...
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Senior Quality Manager CMO
Vor 4 Tagen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Senior Quality Manager CMOAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich,...
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitSenior Quality Manager CMO (m/f/x) – Drug Product ManufacturingKey Responsibilities:Oversee quality oversight at Contract Manufacturing Organizations (CMOs)Act as a global information distributor for quality-related mattersContribute to the further development of the corporate Quality Management System (QMS)Requirements:University degree in a natural or...
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout the Role:We are seeking a highly qualified Senior Quality Manager CMO to join our team at Daiichi Sankyo Europe GmbH. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs).Key Responsibilities:Manage quality oversight at CMOs,...
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Senior Quality Manager CMO
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout the Role:We are seeking a highly qualified Senior Quality Manager CMO to join our team at Daiichi Sankyo Europe GmbH. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs).Key Responsibilities:Manage quality oversight at CMOs,...
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vor 2 Wochen
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Senior Quality Manager CMO
vor 1 Woche
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Senior Quality Manager CMO - Drug Product ManufacturingWe are seeking a highly qualified Senior Quality Manager CMO to join our team at Daiichi Sankyo Europe. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality in our drug product manufacturing processes.Key...
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Senior Quality Manager CMO
vor 1 Woche
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Senior Quality Manager CMO - Drug Product ManufacturingWe are seeking a highly qualified Senior Quality Manager CMO to join our team at Daiichi Sankyo Europe. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality in our drug product manufacturing processes.Key...
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Senior Quality Manager CMO
vor 2 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
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Senior Quality Manager CMO
vor 2 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world, Daiichi Sankyo Europe is a leading pharmaceutical company with over 120 years of experience and a presence in over 20 countries.Our MissionWe strive to become a global pharma innovator with competitive...
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Senior Quality Manager CMO
Vor 3 Tagen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world, Daiichi Sankyo Europe is a leading pharmaceutical company with over 120 years of experience and a presence in over 20 countries.Our MissionWe strive to become a global pharma innovator with competitive...
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Senior Quality Manager CMO
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Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH VollzeitPassion 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...
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Senior Quality Manager CMO
vor 2 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our global...
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Senior Quality Manager CMO
vor 2 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our global...
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Quality Assurance Manager CMO
vor 2 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
Senior Quality Manager CMO
vor 4 Monaten
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 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) – Drug Product Manufacturing
Aufgaben
In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs and your responsibilities include implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements at external contract manufacturers for our oncology products. Furthermore, you support other DS functions as an expert in quality topics and processes.
Profil
- Manage quality oversight at CMOs
- You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
- Define together with the CMO effective CAPAs and track the timely implementation
- As DS QA you independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs
- The QM CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs
- You are involved in establishment of new manufacturing processes and site transfer activities and act as quality subject matter expert supporting PPQ and validation activities
- You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
- In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary
- Act as global information distributor
- In your new role you support global teams and SMEs to identify and define quality needs for CMOs
- You share quality related information from the CMOs to our global stakeholders within the global QA environment as well as in department overarching meetings
- Participate in the further development of the corporate QM-System
- In global working teams you act as SME to improve the DS quality system and global SOP landscape
- Share knowledge and expertise within QA or to other functions to improvement CMO management at DS
In this role you will work 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.
Personal skills and professional experience:
- University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology or a comparable program
- At least five years of relevant work experience in the pharmaceutical industry including:
- at least two years in Quality Assurance and/or Quality Management – preferable in Shop Floor QA activities or as QA Oversight for Manufacturing Activities for Sterile Manufacturing
- at least two years in a GxP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates
- Excellent knowledge of international GMP/GDP regulations
- Expertise in parenteral biological manufacturing particularly in the manufacture of sterile medicinal products or of biological active substances is desired
- 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)
Wir bieten
- Excellent Benefits
- Work-Life Balance
- Growth and Developement
- Health and Wellbeing Support
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