Daiichi Sankyo Europe
Qualified Person für kommerzielle Arzneimittel(m/w/x)
Vollzeit
Senior
Keine Angabe
Pfaffenhofen an der Ilm
DA
Daiichi Sankyo Europe1 Monat
Senior Quality Manager - Monoclonal Antibody Manufacturing(m/w/x)
Vollzeit
Senior
Keine Angabe
85276 Pfaffenhofen an der Ilm
Nejo KI-Zusammenfassung
In this role, you will be the key contact for quality management at contract manufacturing organizations, overseeing compliance with quality standards and regulatory requirements. Daily responsibilities include managing quality issues, supporting inspections, and collaborating with global teams to ensure high-quality products are consistently delivered.
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Anforderungen
- •Master's degree in natural or pharmaceutical sciences, preferably in Biotechnology, Bioengineering, Biochemistry, or comparable program
- •At least five years of relevant work experience in the pharmaceutical industry
- •At least two years in Quality Assurance and/or Quality Management, preferably in Shop Floor QA activities or as QA Oversight for Manufacturing Activities
- •At least two years in a GxP environment involved in monoclonal antibody manufacturing
- •Excellent knowledge of international GMP/GDP regulations
- •Assertiveness and strong communication skills with a diplomatic attitude during negotiations
- •Team player with 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)
Master-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Manage quality oversight at contract manufacturing organizations (CMOs)
- •Address quality topics such as change control, deviations, and complaints related to DS products at CMOs
- •Define effective CAPAs with CMOs and track their timely implementation
- •Review, evaluate, and approve documents like APQRs, PPQ reports, and CPVs
- •Prepare and negotiate QA agreements with CMOs, ensuring compliance with DS QA standards
- •Support establishment of new manufacturing processes and site transfer activities as a quality subject matter expert
- •Assist CMOs during authority inspections and conduct audits on behalf of DS at various suppliers
- •Identify quality risks at CMOs and escalate issues as necessary
- •Distribute quality-related information globally
- •Support global teams and SMEs in identifying and defining quality needs for CMOs
- •Share quality information from CMOs with global stakeholders and during department meetings
- •Act as a subject matter expert in global teams to enhance the DS quality system and global SOP landscape
- •Share knowledge and expertise within QA and other functions to improve CMO management at DS
- •Collaborate closely with Supply Chain, CMC, regulatory functions, and other departments to ensure consistent product quality
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Daiichi Sankyo Europe erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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