Director, External Manufacturing Regulatory Compliance

Get 360Pharma; Beerse; Sur place; EUR 150 000 - 190 000; Plein temps

Résumé du poste

Get 360Pharma is seeking a Director, External Manufacturing Regulatory Compliance Oversight to lead risk-based oversight across the Innovative Medicine External Manufacturing network. You will provide independent assessments, escalate regulatory risks, and drive inspection readiness with partner sites.

In this role you will partner with Quality, Regulatory Affairs, Supply Chain, and Manufacturing Science to strengthen governance, deploy lessons learned, and advance CAPA effectiveness.

Qualifications

• Minimum 12 years of pharmaceutical, biotechnology, biologics, or related GMP experience.
• Minimum 5 years of leadership experience in Quality, Compliance, Regulatory Compliance, Supplier Quality, or External Manufacturing.
• Experience supporting Health Authority inspections, remediation programs, and supplier oversight activities.
• Strong understanding of global GMP regulations and supplier quality management.

Responsabilités

• Monitor and oversee significant compliance risks across external manufacturing partners.
• Provide independent oversight of inspection readiness activities and regulatory inspections.
• Review commitments, remediation plans, and CAPA effectiveness for adequacy and sustainability.
• Support governance forums with risk assessments, trend analyses, and compliance recommendations.
• Lead and develop compliance professionals supporting External Manufacturing oversight.

Connaissances

Leadership

Influence

Stakeholder engagement

Executive communication

Formation

Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related field

Advanced degree preferred

Description du poste

Get 360Pharma is seeking a Director, External Manufacturing Regulatory Compliance Oversight to lead risk-based oversight across the Innovative Medicine External Manufacturing network. You will provide independent assessments, escalate regulatory risks, and drive inspection readiness with partner sites.

In this role you will partner with Quality, Regulatory Affairs, Supply Chain, and Manufacturing Science to strengthen governance, deploy lessons learned, and advance CAPA effectiveness.