CMC Quality Solutions Specialist

Our client, a global pharmaceutical organization, is seeking a professional to support quality assurance activities throughout the product lifecycle. This role involves managing quality processes for late-stage development and commercial products, including submissions, launches, and product improvements.

• Support product change control committees and follow up on associated change controls.
• Maintain and manage the lifecycle of quality assurance product flows and related control documentation.
• Ensure audit and inspection readiness through proactive preparation and participation.
• Review and approve CMC sections for regulatory submissions, renewals, and variations.
• Support the preparation and execution of product launches from a quality perspective.
• Identify risks and propose corrective actions while monitoring product metrics and stability plans.

• You have a Bachelor's Degree.
• You bring 3+ years of experience in the pharmaceutical or biologics industry in a quality management position.
• You possess experience in quality assurance including change control, risk management, and SOP development.
• You have the ability to work autonomously, analyze data for decision-making, and adapt to multi-cultural environments.
• You are proactive and solution-oriented with strong interpersonal and communication skills.
• You are fluent in English.

Nice to Haves

• Operational experience in GMP within quality, manufacturing, or Quality Control.
• Experience with GMP audits, inspections, Data Integrity assessments, or CMC Regulatory requirements.
• Proven skills in project management.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.