![Daiichi Sankyo Europe](https://media.trabajo.org/img/noimg.jpg)
Team Lead
Vor 5 Tagen
**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.
**Team Lead (M/F/x) CMO Management QA**:
**Purpose of the function**:
As Team Lead CMO Management QA you are responsible for leading a team of highly educated and experienced people, which act as primary contact for quality related topics to our Contract Manufacturing Organizations (CMOs) involved in Drug Linker and Drug Substance manufacturing for ADC products. Furthermore, you act as primary contact for assigned overarching, management level related topics for both internal and external stakeholders in an international and very dynamic work environment from development until end of commercial life cycle. Your tasks include day-to-day business as well as strategic related topics and objectives and require communication with different functions and management levels.
**Roles and responsibilities**:
- Manage a team for quality oversight for CMOs located in Europe
- You are responsible as leader for a team of 4-6 people
- You work together with different functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to support your team to solve challenges in the day-to-day business related to CMO Management
- You set strategies for optimal day-to-day business operations for your team and make sure the expectations from internal and external stakeholders are fulfilled
- You understand the needs of your team and you are able to develop people on a personal and professional level
- You are able to interact with management level at CMOs and in case necessary you take over quality-related, overarching topics connected to CMOs
- You are able to review and evaluate documents like APQRs, PPQ reports or CTDs if required
- You support the organization during Authority Inspections in your area of responsibility and perform audits on behalf of DS at different suppliers as needed
- Act as global information distributor
- You monitor quality-related information from different markets to ensure early recognition of trends related to your area of responsibility
- You provide such information to global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures
- Participate in the further development of the corporate QM-System
- You act as a SME to help improving the global Daiichi-Sankyo QMS and global SOP landscape
- Share knowledge and expertise within the DS network to improve QA and CMO management at DS
In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, Regulatory Affairs and others to ensure consistent supply to markets with products which meet our high-quality standards at any time. This requires an extensive understanding of the pharmaceutical industry and multi-cultural work environments.
Personal skills and professional experience:
- University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Biology, Chemestry or a comparable program
- At least 8+ years of relevant work experience in the pharmaceutical industry including:
- at least 4+ years in Quality Assurance and/or Quality Management - preferable in different functions as Shop Floor QA, QA Oversight for Manufacturing Activities and/or global QA roles
- at least 2+ year experience of working in a GMP in manufacturing for monoclonal anti-bodies and/or biological APIs
- Experience with ADC manufacturing is a strong plus
- At least 4+ years experience as team leader with at least 4-5 direct reports
- Excellent knowledge of international GMP/GDP regulations
- Experience in managing relationship to C(D)Mos or external supplier organizations
- Proven track record of Project management and Leadership skills in Matrix Organizations is beneficial
- Very good knowledge of CMC regulatory and development - relevant work experience in these fields is a plus
- Understanding of manufacturing steps for Drug Linker & Drug Substance manufacturing of ADCs
- Have assertiveness, strong communication skill paired with diplomatic attitude during negotiations
- A true team player, high quality consciousness and a solution-oriented mindset
- Manage senior level relationships within the company and with external partners
- Very good
-
Pharmaceutical Industry Expert Team Lead Role
vor 3 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative solutions that improve the quality of life for patients worldwide. We are seeking an experienced Pharmaceutical Industry Expert Team Lead to join our team in Munich, Germany.As a Team Lead, you will be responsible for managing a team of...
-
Team Lead Capex Procurement
vor 6 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...
-
Team Lead Process Automation
vor 6 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH VollzeitEngagiert in der Forschung. Im Einsatz für Patient*innen. Mit über 120 Jahren Erfahrung und mehr als Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern. In Europa konzentrieren wir uns auf zwei Bereiche: Unser...
-
Team Lead Capex Procurement
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 is...
-
Team Lead
vor 6 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe VollzeitEngagiert in der Forschung. Im Einsatz für Patient*innen. Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern. In Europa konzentrieren wir uns auf zwei Bereiche:...
-
Team Lead
Vor 4 Tagen
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH VollzeitWith 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...
-
Team Lead
vor 6 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...
-
Team Lead
Vor 3 Tagen
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH VollzeitWith 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...
-
Team Lead
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...
-
Cmc Lead
vor 6 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...
-
Lead Pharmaceutical Technical Expert
vor 3 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitJob SummaryWe are seeking a highly skilled Lead Pharmaceutical Technical Expert to join our team at Daiichi Sankyo Europe GmbH. The successful candidate will be responsible for leading the development and implementation of technical strategies to ensure the highest quality drug products.About Daiichi Sankyo Europe GmbHDaiichi Sankyo is a global...
-
Team Lead
vor 6 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe VollzeitDisziplinarische Führung: Sie leiten das Team Process Automation mit ca. 6 Mitarbeitenden und sorgen für eine motivierende und leistungsfördernde Arbeitsatmosphäre - Strategische Projektierung: Sie entwickeln und setzen Strategien für moderne und innovative digitale Technologien in der Produktion und Verpackung um - Technologie-Management: Sie suchen,...
-
Lead Buyer Capex
vor 6 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...
-
Project Lead
vor 6 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...
-
Senior Tech Management Lead
vor 7 Stunden
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit**Engagiert in der Forschung. Im Einsatz für Patient*innen.**: Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern. In Europa konzentrieren wir uns auf zwei Bereiche: Unser...
-
Lead Buyer
vor 6 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...
-
Lead Buyer
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...
-
Team Lead
vor 6 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe VollzeitEngagiert in der Forschung. Im Einsatz für Patient*innen. Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern. In Europa konzentrieren wir uns auf zwei Bereiche:...
-
Tech Management Lead
vor 4 Wochen
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH VollzeitWith 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...
-
Tech Management Lead
vor 1 Monat
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH VollzeitWith 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...