NEW OPPORTUNITY | CMC Quality Solutions Specialist | Biopharma

Project : Freelance or Randstad employee

Are you a Quality Assurance professional with a passion for product lifecycle management? ?

I am currently partnering with a leading global biopharmaceutical company to find their next CMC Quality Solutions Specialist. In this role, you will be instrumental in supporting QA activities for both commercial products and those in late-stage development.

What will your day-to-day look like?

Collaborating closely with CMC Quality Leads and global cross-functional teams, your 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 adecuado 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 [email protected]

📌 Cmc quality solutions specialist (España)
🏢 Randstad Belgium
📍 España