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QA Consultant for CMO Management Small Molecules (M/F/D)
Tasks:
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 .
Qualification:
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
Requirements:
Start: 15.11.2026
Duration: 10 months
Capacity: 5 days per week
Location: 100% remote
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