Bio DS internal auditor

Audit & Compliance

• Plan, conduct, and document internal audits using a risk-based methodology focused on high-impact processes.
• Perform comprehensive on-the-floor observations, assess findings according to their level of criticality, and recommend practical and proportionate corrective actions.
• Support inspection readiness activities and participate in regulatory inspections.

Inspection Readiness

• Contribute to the development, implementation, and continuous monitoring of the site Inspection Readiness Plan, ensuring proactive identification of gaps and timely closure of action items.
• Coordinate and track inspection readiness activities across QA and Production departments to ensure a consistent state of preparedness.

Coaching & Training

• Act as a coach and trainer for QA and Production teams on internal auditing practices, ensuring a consistent audit approach and strong auditing capabilities across departments.
• Provide guidance on regulatory expectations and audit methodologies.

Continuous Improvement & Quality Governance

• Provide analysis, systemic observations, and performance insights to Quality Governance bodies.
• Identify recurring issues and recommend sustainable, structural solutions aligned with both quality and operational objectives.
• Monitor CAPA implementation and evaluate long-term effectiveness.

Quality Culture

• Promote awareness and understanding of applicable regulatory requirements and Quality Management System expectations across the Braine Bio DS organization.
• Support network initiatives related to inspection readiness and audits, ensuring effective local implementation and acting as the local interface for global initiatives.
• Benchmark external industry practices and trends, and share relevant insights with the department.
• Serve as a quality mentor and coach regarding the interpretation and application of regulatory and global requirements for Braine Bio DS personnel.

EDUCATION & QUALIFICATIONS

Minimum Education Requirements

• Bachelor’s Degree required
• Master’s Degree preferred

Additional Certifications / Qualifications

• Relevant certification in Quality Management, Auditing, or GMP compliance is considered an asset.

COMPETENCIES

Basic Requirements

• Minimum of 10 years of experience in the pharmaceutical industry.
• Proven experience in Quality Systems and/or Quality Compliance.
• Demonstrated experience as an internal auditor.
• Strong ability to collaborate and influence across departments and organizational levels.
• Fluent in both French and English.
• On-site presence required.

Additional Skills / Preferred Qualifications

• Experience in biological drug substance manufacturing and/or quality operations is highly desirable.
• Ability to work effectively in a fast-changing and evolving environment, demonstrating agility and adaptability.
• Strong resilience and stress-management capabilities.

• 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.
• Bouw je netwerk uit en beleef onvergetelijke momenten tijdens exclusieve events en afterworks.
• 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.