Director – Quality Compliance
Reports to: VP Quality

Role Summary:
Responsible for overseeing and maintaining the Quality Management System (QMS) across the development and commercial lifecycle of a combination product. Ensures alignment with regulatory frameworks (GxP, ISO 13485) and readiness for Pre-Approval Inspection (PAI) internally and with external partners.

Primary Responsibilities:

• Maintain and oversee company-wide QMS compliance for combination products.
• Lead quality review boards and cross-functional quality governance meetings.
• Define and monitor quality metrics across departments.
• Represent QA in cross-functional teams, provide compliance guidance per global regulatory expectations.
• Conduct and oversee gap assessments against applicable regulations and guidelines.
• Evaluate and select external vendors; lead qualification and auditing processes.
• Manage internal and external audit schedules; ensure audits are performed, documented, and followed up.
• Coordinate PAI readiness activities, including for strategic partners.
• Prepare, review, and approve Quality and Technical Agreements.
• Develop and maintain procedures related to CAPA, complaints, deviations, change control, risk management, and training.
• Monitor updates in regulations, standards, and guidance documents; ensure company systems remain compliant.
• Train and supervise Quality Compliance personnel.
• Author and review compliance-related documentation: SOPs, protocols, risk files, audit reports.

Skills and Experience Requirements:

• Degree in life sciences or related field.
• 5+ years in QA roles within pharma/biotech or medtech sectors.
• Hands-on experience with QMS setup and maintenance under ISO 13485 and GxP.
• Familiar with requirements related to combination products.
• Experience managing audits and regulatory inspections.
• Proficient in English and Hebrew, written and spoken.
• Skilled in Microsoft Office; PLM/QMS software familiarity preferred.

Additional Information:

• Travel: Up to 20% (international)
• Must be capable of managing multidisciplinary processes in regulated environments.