DSP Bio DS Operations Quality Specialist

Our client, a leading pharmaceutical company, is seeking a specialist to oversee downstream quality assurance activities within a new commercial biologicals drug substance facility. The role focuses on ensuring compliance with internal standards while driving continuous improvement across manufacturing operations to maintain high product quality and safety.

• Oversee downstream quality assurance activities specifically related to DSP manufacturing operations.
• Review and approve GMP documentation including SOPs and Master Batch Records.
• Perform batch record review of production intermediates and provide quality oversight on the shop floor.
• Review and approve deviations, CAPA, and change controls while ensuring appropriate escalation of quality issues.
• Identify production quality challenges and implement actions to improve floor practices and processes.
• Train and coach personnel to ensure a high level of process and quality knowledge across the team.

• You have a Bachelor or Master’s degree in a scientific field such as Biotechnology, Chemistry, or Pharmacy.
• You bring 8+ years of experience within a GMP environment.
• You possess demonstrated expertise in DSP biologicals drug substance operations from a business or quality perspective.
• You have strong communication skills and the ability to remain effective in high-pressure situations.
• You are fluent in French and English.

Nice to Haves

• Knowledge of other biomanufacturing processes including validation, maintenance, and metrology.
• Ability to create support materials for technical training.

• 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.