CMC Quality Solutions Specialist
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key responsibilities
will include:
- Supporting Product Change Control Committees and ensuring follow-up.
- Driving audit and inspection readiness.
- Reviewing and approving CMC sections for regulatory submissions, variations, and renewals.
- Preparing product launches from a QA perspective (shipping validation, complaint readiness, etc.).
- Managing risk mitigation and QA product flows.
- For commercial products: Providing oversight on product quality complaints, recalls, and annual reporting. The ideal profile:
- You hold a Bachelor’s Degree (or higher) in a relevant scientific field.
- You have a minimum of 8 years of experience in the pharmaceutical or biologics industry, specifically in Quality Management.
- You are fluent in English, with excellent communication and presentation skills.
- You are an autonomous, analytical thinker who thrives in a collaborative, multi-cultural environment.
- Nice-to-haves: Operational GMP experience, knowledge of CMC regulatory requirements, or hands-on experience in GMP audits and Data Integrity. Why join? This is a fantastic opportunity to bring your expertise to a global player, suggest harmonizations across global products, and ensure the highest quality standards for life-changing treatments. 📩 Ready for your next challenge? Feel free to reach out to me via DM or send your CV directly to mehdi.soli.soli@randstad.be
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