Hoyer BV vacatures

Role Overview

As a Quality Director, you will be responsible for providing strategic direction and leadership to our entire Quality function. Reporting directly to the CEO, you will develop and execute a robust quality strategy, ensure unwavering compliance with international regulatory standards, and foster a culture of continuous improvement and operational excellence across all our manufacturing sites and external partners.

Key ResponsibilitiesQuality Strategy & Compliance

Define and execute a quality strategy aligned with global standards (cGMP, FDA, EMA, WHO, SFDA).

Ensure full compliance across all manufacturing sites, CMOs, and API suppliers.

Operational Quality Oversight

Lead QA, QC, and Microbiology to ensure efficient batch release and reliable market supply.

Oversee accurate testing, batch release, and stability programs.

Regulatory Inspections & Audits

Manage preparation and response for regulatory inspections (FDA, EU QP, WHO, etc.).

Liaise with regulatory agencies during inspections and audits, ensuring prompt, transparent, and compliant responses to findings)

Risk Management & Improvement

Lead risk identification, mitigation, and quality improvement initiatives.

Cross-functional Collaboration

Collaborate with senior leadership and other departments, including R&D, regulatory affairs and operations to resolve quality issues and develop innovative solutions.

Support product development teams to ensure quality is embedded into new product development from the outset.

Qualifications

• Education: Bachelor’s in pharmacy (mandatory); master’s or certification in Quality Management (preferred).
• Experience: 20+ years in pharmaceutical QA/QC, with 10+ years in senior leadership.
• Expertise in global cGMP, QMS, and regulatory compliance (FDA, EMA, SFDA, WHO).
• The Role rquires frequent Travel overseeing Operations at our sites in Cairo & KSA
• Proven track record in branded generics and international regulatory frameworks.
• Solid performance in driving quality improvements and managing cross-functional teams.
• Strong expertise in quality management systems, risk management, CAPA, and root cause analysis

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