Internal Operations Quality Partner

• Work closely with the Internal Bio Clinical Manufacturing Team to ensure that the Quality Management System supporting product development and clinical supplies is effective, ensuring product quality, safety, and efficacy while meeting regulatory requirements and expectations in a fit-for-purpose and efficient manner.
• Perform quality review of master and executed batch records for drug substance supporting clinical trial studies.
• Perform release of production intermediates.
• Drive continuous QA improvement processes. Ensure appropriate documentation systems and processes are in place and followed for development projects (SOPs, protocols, report review).
• Plan and conduct compliance tours and on-the-floor GMP spot checks, providing quality assurance support including inspection activities.
• Partner with other departments to identify, mitigate, and resolve compliance and quality issues (investigations, deviations, out-of-specifications) that may impact development activities and products.
• Support change control processes and perform QA evaluations.

Education :

• Bachelor’s Degree (required)
• Master’s Degree (preferred)
• PhD / Law (J.D.) / Medical Degree (M.D.) / Other: N/A

Required skills, knowledge, and experience:

• Bachelor’s or Master’s degree in a scientific field.
• Minimum of 5 years of experience in a GMP environment.
• Strong knowledge of the pharmaceutical biologics industry and relevant technical aspects.
• Experience with quality systems including deviations, CAPA, and change controls.
• Good understanding of current regulatory requirements and the ability to interpret them in a product development context.
• Strong communication skills with internal and external stakeholders.
• Ability to work independently and proactively.
• Capable of acting without direct supervision and managing complex or urgent situations.
• On-site presence required (approximately 60%).
• Strong written and verbal communication skills in English.

• 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.