Expert (M/F/x) Cmo Quality Management

vor 1 Woche

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo, Inc. Vollzeit

Expert (M/F/x) CMO Quality Management

Purpose of the function:
In your new role you support the primary contact for quality related topics (CMO-MQ) at contract manufacturing organizations (CMOs). You support the management of the quality oversight at the CMOs, which includes the implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements for our oncology products. Furthermore, you support other DS functions in quality-related topics and processes.

Roles and responsibilities:

- Manage quality oversight at CMOs
- You support the responsible person for quality related topics like change control, deviations and/or complaints related to DS products at CMOs and process independently assigned tasks
- You track the timely implementation of CAPAs related to deviations or audit findings and check the effectiveness in collaboration with the CMO and internal stakeholders
- You review, evaluate and approve documents like complaint investigations, deviation reports or change controls and ensure relevant stakeholders are included whenever necessary
- You ensure the CMO operates in compliance to the established QAA and international GMP guidelines
- You support CMO-MQs during Authority Inspections at different suppliers as needed
- You collect data from CMOs and process the data as described per internal SOPs
- 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 whenever necessary
- Participate in the further development of the corporate QM-System
- You support global working teams to improve the DS quality system and global SOP landscape

In this role you will work globally in close cooperation with other departments like Supply Chain, Tech Management, Regulatory Affairs 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:

- Bachelor degree in natural or pharmaceutical sciences with at least 3 years relevant professional experience or OR vocational training in pharmaceutical business with at least 6 years relevant professional experience
- At least 3 years of relevant work experience in the pharmaceutical industry including:

- at least 1 years in Quality Assurance and/or Quality Management - preferable in Shop Floor QA activities or as QA Oversight for Manufacturing Activities
- at least 2 years in a GxP environment in a position involved in manufacturing or comparable activities
- Excellent knowledge of international GMP/GDP regulations
- 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
- Willingness to travel (up to 10%, domestic and international)

  • Expert (m/f/x) CMO Quality Management

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit 60.000 € - 120.000 € pro Jahr

    Passion for Innovation. Compassion for Patients.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...

  • Senior Quality Manager CMO

    Vor 5 Tagen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Vollzeit 80.000 € - 120.000 € pro Jahr

    For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:Senior Quality Manager CMO (m/f/x) – Monoclonal Antibody ManufacturingPurpose of the function: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...

  • Senior Quality Manager CMO

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit 60.000 € - 120.000 € pro Jahr

    Passion for Innovation. Compassion for Patients.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...

  • Expert Quality Assurance

    Vor 7 Tagen

    Bad Homburg vor der Höhe, Deutschland Fresenius Medical Care Vollzeit

    Goal of function: This function provides key support to the Manufacturing Quality operations at our Ober-Erlenbach site, by monitoring, implementing, executing, and coordinating the activities and requirements related to the Production Responsibility over the applicable Disinfectant Contract Manufacturing Organizations (CMOs). Your Responsibilities: -...

  • Lead Buyer

    vor 2 Wochen

    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 7 Tagen

    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...

  • Regional Process Lead

    Vor 2 Tagen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    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...

  • Head (M/F/x) of Bioconjugation Research

    vor 1 Woche

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo, Inc. Vollzeit

    Head (M/F/x) of Bioconjugation Research Position: The Head of Bioconjugation will be in charge to lead the establishment of a new drug substance development and production unit for Antibody-Drug Conjugates (ADC). This includes the establishment of a new bioconjugation process development laboratory as well as the construction of a GMP bioconjugation area as...

  • Lead Buyer Capex

    vor 1 Tag

    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...

  • Regional Process Lead

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Job DescriptionWith 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...