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

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 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.

Roles and responsibilities:

• 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.

Personal skills and professional experience:

• 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)

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.eu