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.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
• Versnel je carrière met een helder groeipad, coaching en mentoring ter ondersteuning.
• Werk in een dynamische en ondersteunende omgeving waar je echt het verschil kunt maken.
• Werk waar en wanneer je het beste presteert voor een ideale werk-privébalans.
• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
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• Breid je vaardigheden uit met externe opleidingen en onze in-house Pauwels Academy.
• Werk aan uitdagende projecten met toonaangevende klanten in Life Sciences, Engineering & Digital.
• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.