QA Consultant for CMO Management Small Molecules
Invenda GmbH
Ansprechpartner: Aleksandra Ivanova
München, Deutschland
Beschreibung
In 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.
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
Information Distribution within QA and Other Departments:
- 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
Support for Global and Regional QA Functions:
- 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
In this role, you will engage in ad hoc and project-based technical exchanges with the Supply Chain, CMC, and Regulatory Affairs departments, as needed to ensure consistent supply to markets with products that meet our high quality standards at all times .
Education/Experience:
- 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
Competencies:
- 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