CMC Quality Solutions Specialist

Randstad Belgium; Waals-Brabant; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Randstad Belgium is seeking a CMC Quality Solutions Specialist for a leading global biopharmaceutical company. You will support QA activities across commercial products and late-stage development from a QA perspective.

Collaborate with CMC leads and cross-functional teams to manage change control, audits, regulatory submissions, product launches, and risk mitigation in a GMP environment.

Qualifications

• Bachelor’s Degree in a relevant scientific field.
• Minimum 8 years of experience in the pharmaceutical or biologics industry, specifically in Quality Management.
• Fluent in English with excellent communication and presentation skills.
• Autonomous, analytical thinker in a collaborative, multi-cultural environment.

Responsabilités

• Support Product Change Control Committees and follow-up.
• Drive audit and inspection readiness.
• Review and approve CMC sections for regulatory submissions, variations, and renewals.
• Prepare product launches from a QA perspective (shipping validation, complaint readiness, etc.).
• Manage risk mitigation and QA product flows.
• For commercial products: oversee product quality complaints, recalls, and annual reporting.

Connaissances

Quality Management

Regulatory knowledge

Analytical thinking

Communication skills

Formation

Bachelor’s degree in a relevant scientific field

Description du poste

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 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.

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.