Senior Quality Manager CMO
vor 5 Monaten
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 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
Purpose of the function:
Roles and responsibilities:
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-
Senior Quality Manager CMO
vor 1 Monat
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitPassion for Innovation. Compassion for Patients.Daiichi Sankyo Europe is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.We are seeking a highly qualified candidate to fill...
-
Senior Quality Manager CMO
vor 6 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe 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...
-
Quality Assurance Manager
vor 2 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeWe are a global pharmaceutical company dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. With over 120 years of experience and more than 17,000 employees in over 20 countries, we strive to protect people from cardiovascular disease, the leading cause of...
-
Team Lead
vor 5 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit**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...
-
European Quality Assurance Director
Vor 3 Tagen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeWith 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: cardiovascular disease and oncology. We strive to become a global...
-
Team Lead
vor 5 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe 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...
-
Senior Manager, R&D Quality Lead
vor 1 Monat
Marburg an der Lahn, Hessen, Deutschland CSL VollzeitJob DescriptionWe are seeking a highly skilled Senior Manager, R&D Quality to join our team at CSL. The successful candidate will be responsible for managing the integration of R&D quality systems, policies, and procedures in line with our Global Quality Management System (QMS) for Product Development.Key ResponsibilitiesDevelop and maintain...
-
Product Owner Quality
vor 5 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe VollzeitAs Product Owner Quality (POQ) you are responsible for ensuring quality oversight for one product at a global level. You act as primary quality contact for the assigned product for both internal and external stakeholders in an international and very dynamic work environment from development until end of commercial life cycle. To do this, you communicate with...
-
Product Owner Quality
vor 5 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe 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...
-
Senior Quality Specialist
vor 3 Monaten
Marburg an der Lahn, Deutschland CSL Behring VollzeitFür unsere Abteilung **Quality Assurance **in Marburg suchen wir aktuell einen Senior Quality Specialist (m/w/x) R-242758 Vollzeit / unbefristet/ Tarif Interner Job Titel: Senior Quality Specialist Internes Ausschreibungsende: 25.09.2024 Sie sind im Bereich Quality im Rahmen der Abweichungsbearbeitung, Change-Control, Inspektionen und übergreifenden...
-
Senior Software Engineer
vor 4 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Avantgarde Experts VollzeitAbout the Role:We are seeking a skilled Senior Software Engineer to join our team and contribute to the development of our full stack solutions. The ideal candidate will have expertise in full stack development and be able to work collaboratively with our team to deliver high-quality software products.Key Responsibilities:Design, develop, and maintain full...
-
(Senior) Business Development Manager
vor 4 Wochen
Pfaffenhofen an der Ilm, Deutschland Avantgarde Experts VollzeitIm Bereich Marketing & Kommunikation besetzen wir interessante Stellen in ganz Deutschland - bei attraktiven Kunden, vom Junior Produktmanager bis zum Head of Marketing (m/w/d). Interessiert? Dann gleich bei AVANTGARDE Experts bewerben! Für unseren Kunden, ein erfolgreiches Online-Unternehmen, besetzen wir ab sofort folgende Position in unbefristeter...
-
Quality Compliance Professional
vor 3 Wochen
Biberach an der Riß, Baden-Württemberg, Deutschland engineering people GmbH VollzeitSenior Quality Compliance ManagerWir suchen eine erfahrene Person für unsere Abteilung Qualitätssicherung und Compliance. Die Position besteht in der Bearbeitung von GMP-Prozessen zur Qualifizierung von Disposables und Packmitteln, der Durchführung von Änderungsanträgen und der Erstellung von GMP-Dokumenten. Die Zusammenarbeit mit anderen Abteilungen,...
-
(Senior) Business Development Manager
vor 4 Wochen
Pfaffenhofen an der Ilm, Deutschland Avantgarde Experts VollzeitIm Bereich Marketing & Kommunikation besetzen wir interessante Stellen in ganz Deutschland - bei attraktiven Kunden, vom Junior Produktmanager bis zum Head of Marketing (m/w/d). Interessiert? Dann gleich bei AVANTGARDE Experts bewerben! Für unseren Kunden, ein erfolgreiches Online-Unternehmen, besetzen wir ab sofort folgende Position in unbefristeter...
-
Senior Software Engineer
vor 4 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland DEUTSCHEFACHPFLEGE VollzeitWe are looking for a skilled Senior Software Engineer to join our team. As a key member of our development team, you will be responsible for designing, implementing, and maintaining our cloud-based software systems.Main Responsibilities:Design and develop scalable, cloud-based software systemsCollaborate with cross-functional teams to identify and prioritize...
-
Senior Quality Specalist
vor 5 Monaten
Marburg an der Lahn, Deutschland Proclinical Staffing VollzeitStellenbeschreibung: Senior Quality Specalist (m/w/d) Für einen unserer internationalen Pharma Kunden, suchen wir aktuell Unterstützung als Senior Quality Specalist(m/w/d) in Marburg. **Wir bieten**: - Ein attraktives Gehaltspakt - 30 Tage Urlaub / Jahr - Flexible Arbeitszeiten - Großer Home-Office Anteil nach der Einarbeitung...
-
Senior Quality Specialist M/w/x
vor 2 Monaten
Marburg an der Lahn, Deutschland CSL Behring VollzeitFür unsere Abteilung **Quality Assurance **in Marburg suchen wir aktuell einen Senior Quality Specialist (m/w/x) R-243376 Vollzeit / unbefristet/ Tarif Interner Job Titel: Senior Quality Specialist Internes Ausschreibungsende: 09.10.2024 Sie sind im Bereich Quality involviert in den APQR, die Abweichungsbearbeitung und die Inspektionen. Sie stellen...
-
Senior Quality Specialist
vor 6 Monaten
Marburg an der Lahn, Deutschland Hays Vollzeit**Senior Quality Specialist** (m/w/d) **Anstellung bei der Hays Professional Solutions GmbH** **Marburg** **Startdatum: sofort** Referenznummer: 755652/1 **Bewerbung starten** **Ihre Aufgaben**: - Qualitätsmanagement (Quality Oversight) im Verantwortungsbereich unter allgemeiner Anleitung des Vorgesetzten - Fortlaufende Betreuung und...
-
Senior Director, Quality Control Operations
vor 2 Monaten
Marburg an der Lahn, Deutschland CSL Behring VollzeitIn this role, you will be reporting to the CSL Global Head of Quality Control who will provide strong leadership and strategic direction to the quality control organization as well as building and maintaining a strong quality culture within CSL. In this position you will manage, direct and maintain the company’s global operational quality control...
-
Senior Quality Specialist
vor 6 Monaten
Marburg an der Lahn, Deutschland Oxford Global Resources VollzeitLocation: Marburg, Germany - Contact: Jessica Kolbert - Job type: Temp to Perm - Industry: Pharmaceutical Werden Sie Teil eines dynamischen Teams bei einem unserer Kunden als Senior Quality Specialist und tragen Sie zum Engagement des Unternehmens für Spitzenleistungen bei! In dieser Funktion sind Sie an vorderster Front für die Überwachung der Qualität...
