Regulatory Compliance Executive
4 days ago
Position Overview: We are seeking a seasoned and strategic Vice President of International Quality to lead our quality assurance and control initiatives, ensuring compliance to global QMS and regulations. This key leadership role sits on the international business leadership team and participates in strategic planning in collaboration with cross-functional departments to promote a culture of quality and continuous improvement while ensuring high-quality product supply to customers globally.
Key Responsibilities:
- Lead other quality leaders responsible for Europe, Middle East, Canada, Asia Pacific, and LATAM countries.
- Provide direction and mentorship to team members in alignment with Corporate Quality.
- Direct responsibility for establishing and maintaining global Quality Management Systems, customer complaints, adverse event reporting, NCE/CAPA, distribution, and service quality.
- Develop and implement employee communication and training programs in connection with Hologic quality objectives, strategies, and processes.
- Establish and maintain relationships with regulatory bodies and industry associations.
Requirements:
- Established executive-level experience in quality assurance and control within the medical device or pharmaceutical industry.
- In-depth knowledge of international regulatory standards and quality systems.
- Qualified to degree level in engineering or related field with a Master's preferred (MBA, Quality Management, or Engineering).
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