CMC Quality Solutions Specialist
Contracting – Brabant Wallon
Your responsibilities:
- Preparing and coordinating Change Control Committee meetings (documentation review, ensuring readiness).
- Supporting QMS maintenance: follow‑up of changes, documentation updates.
- Managing deviations: creation and follow-up.
- Performing QRR assessments for product launches to ensure compliance with regulatory requirements.
- Collecting and consolidating relevant information for MedInfo questions.
- Taking meeting minutes, asking the right questions, challenging stakeholders with solid QA arguments.
- Supporting transversal initiatives (process improvements, QA–RA alignment).
- Building and maintaining product QA knowledge (SharePoint, documentation).
Your profile:
- Minimum 6 years of experience (flexibility if slightly below, e.g., internships may help but not fully replace).
- Strong experience in pharmaceutical or biotech industry is preferred.
- Experience in operations/production is a strong plus.
- Fluent English & French
- Strong Quality Assurance mindset and QA background.
- Ability to understand scientific/technical discussions (even if scientific ownership stays with the CMC Lead).
- Experience in GMP / QA processes (change control, deviations, QMS support).
- Ability to handle pushback, challenge stakeholders, and defend QA standards with solid arguments.
- Excellent communication & coordination skills.
- Ability to work autonomously, analyze data, and make decisions.
- Good comprehension of regulatory/CMC requirements.
Nice to have:
- Experience in Data Integrity (mindset more important than hands‑on reporting).
- Experience in GMP audits & inspections.
- Project management skills.
- Background in production/manufacturing to better understand operational partners.
- Knowledge of biologics + small molecules (products can be pharma or bio).
Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]