* 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.
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.
Requirements
Education & Qualifications
* 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
* 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.
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