Qualitätsmanager (m/w/d) für CMO Management Small Molecules
Randstad DeutschlandIn your role, you advice a small molecules project from QA perspective, which will be affected by some changes to supply chain situation (e.g. new sites/suppliers).
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 involved CMO/manufacturing site, which includes the implementation and maintenance of Daiichi Sankyo quality standards (GMP/GDP) as described per quality agreements and international regulatory requirements.
Furthermore, you advice other DS functions as an expert in quality-related topics and processes and support the global organization in product oversight.
The project can be done 100 % remote.
Quality Oversight At CMO/Manufacturing Site
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 involved CMO/manufacturing site, which includes the implementation and maintenance of Daiichi Sankyo quality standards (GMP/GDP) as described per quality agreements and international regulatory requirements.
Furthermore, you advice other DS functions as an expert in quality-related topics and processes and support the global organization in product oversight.
The project can be done 100 % remote.
Quality Oversight At CMO/Manufacturing Site
- Handle quality-related topics such as change control, deviations, and/or complaints related to the manufacturing of DS products at CMOs
- Define effective CAPAs together with the CMO and track timely implementation
- Review, evaluate, and approve documents such as APQRs, PPQ reports, and CPVs
- Prepare and negotiate QAAs with CMOs and ensure that CMOs work in accordance with DS QAAs
- Technical advice CMOs during authority inspections and audits on behalf of DS at different suppliers
- Identify quality risks at CMOs and escalate issues where necessary
- Technical advice local and global teams and SMEs to identify and define quality needs for CMOs
- Share quality-related information from CMOs with regional and global stakeholders within the QA environment as well as in cross-departmental meetings
- Distribute information from stakeholders to the CMO and ensure timely implementation of agreed requirements
- Technical advice regional QA functions for regulatory requests regarding e.g. GMP clearance or import licence
- Share knowledge and expertise within QA and other functions to improve CMO management at DS
- University/FH/Master's degree in natural or pharmaceutical sciences preferred 5 years + of experience in the pharmaceutical industry
- Experience specifically in Quality Assurance (QA), Quality Management Systems (QMS), and a GMP-regulated environment
- Experience with managing CMOs or external suppliers is beneficial
- Excellent knowledge of international GMP/GDP regulations
- Expertise in small molecule manufacturing for Drug Substance and Drug Product
- Assertiveness and strong communication skills paired 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
- Project management skills are desirable
- Attractive options for shortening your personal payment term
- No more time-consuming invoicing
- Fast, reliable payment of fees
- Conclude project contracts by means of electronic signature