Senior Quality Manager CMO - Monoclonal Antibody Manufacturing(m/w/x)

## Passion for Innovation. Compassion for Patients. 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. For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position: ## Senior Quality Manager CMO (m/f/x) – Monoclonal Antibody Manufacturing ## Purpose 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 at the CMOs. 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. ## 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 Biotechnology, Bioengineering, Biochemistry 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 * at least two years in a GxP environment in a position involved in monoclonal antibody manufacturing * 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 * Project management skills is a plus * Willingness to travel (up to 10%, domestic and international)