Head of Quality Control

The Head of Quality and Regulatory will provide strategic and operational leadership for quality assurance, quality control, and regulatory compliance across the company’s pharmaceutical products and imaging systems. This full-time, on-site position.

The Head of Quality and Regulatory will be responsible for developing, implementing, and maintaining robust Quality Management Systems (QMS) that meet applicable pharmaceutical, medical device, and regulatory requirements. This role will oversee quality systems, regulatory submissions, audits, inspections, product release, compliance activities, and continuous improvement initiatives across manufacturing and distribution operations.

The successful candidate will partner closely with cross-functional and senior leadership teams to establish quality standards and policies, manage deviations and CAPAs, identify and mitigate quality and regulatory risks, and ensure products consistently meet internal specifications and applicable regulatory requirements. This role will also lead and develop quality and regulatory personnel, serve as a key company representative during regulatory inspections, and provide strategic guidance on evolving regulatory requirements.

• Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) across pharmaceutical products and medical devices.
• Establish and maintain quality policies, procedures, standards, and objectives to ensure compliance with FDA, EMA, ISO, GMP, GCP, and other applicable regulatory requirements.
• Oversee Quality Assurance and Quality Control activities, including product testing, specifications, product release, and ongoing quality monitoring.
• Lead regulatory compliance activities, including the preparation and management of regulatory submissions, approvals, registrations, and ongoing product compliance requirements.
• Serve as the primary quality and regulatory representative during FDA, international regulatory, customer, and third-party inspections and audits.
• Develop and oversee internal and external audit programs and ensure timely identification, investigation, and resolution of compliance gaps.
• Establish and manage processes for deviations, nonconformances, investigations, corrective and preventive actions (CAPA), change control, and quality risk management.
• Partner with Manufacturing, Operations, Engineering, Supply Chain, R&D, and other cross-functional teams to identify and mitigate quality and regulatory risks.
• Monitor and analyze quality metrics, trends, and performance data to identify risks, opportunities for improvement, and areas requiring corrective action.
• Lead continuous improvement initiatives that strengthen quality systems, improve operational performance, and maintain regulatory compliance.
• Ensure quality and regulatory requirements are integrated into manufacturing, distribution, and product lifecycle processes.
• Develop, review, and approve SOPs, quality policies, technical documentation, regulatory documentation, and other controlled quality records.
• Monitor changes in applicable regulations, standards, and industry expectations and develop strategies to ensure continued compliance.
• Establish and oversee quality and regulatory training programs to ensure employees understand and consistently follow applicable requirements.
• Recruit, develop, mentor, and lead quality and regulatory personnel while fostering a culture of accountability, compliance, and continuous improvement.
• Provide senior leadership with strategic guidance regarding quality risks, regulatory requirements, compliance initiatives, and emerging industry developments.
• Collaborate with senior leadership to establish quality objectives and ensure quality…