Job Description

Rx Group is recruiting a quality director, site head for a clinical-stage gene therapy biotech based in Florida.

Job Summary:

The successful candidate will play a pivotal role in ensuring the highest standards of quality, compliance, and regulatory adherence throughout clinical-stage gene therapy operations. Reporting to the Vice President of Quality, the Site Quality Assurance Director will be responsible for overseeing all aspects of quality assurance activities, driving continuous improvement initiatives, and fostering a culture of quality excellence within the organization.

Key Responsibilities:

• Leadership: Provide strategic leadership and direction to the site quality assurance team, fostering a collaborative and high-performance culture focused on quality and compliance.
• Quality Management Systems (QMS): Develop, implement, and maintain robust quality management systems in accordance with applicable regulations and industry standards (e.g., FDA, EMA, ICH).
• Regulatory Compliance: Ensure compliance with relevant regulatory requirements, guidelines, and standards for clinical-stage gene therapy products, including GxP, ICH, and cGMP.
• Audits and Inspections: Plan and coordinate internal and external audits, inspections, and assessments, driving timely resolution of findings and implementation of corrective/preventive actions.
• Document Control: Oversee document control processes, including document creation, review, approval, distribution, and retention, to ensure accuracy, completeness, and compliance.
• Training and Development: Implement training programs to ensure staff competency in quality and regulatory requirements, promoting a culture of continuous learning and development.
• Risk Management: Lead risk assessment activities to identify, evaluate, and mitigate quality and compliance risks associated with gene therapy manufacturing and testing processes.
• Supplier Quality Management: Collaborate with cross-functional teams to establish and maintain robust supplier quality management programs, including supplier qualification, audits, and performance monitoring.
• Continuous Improvement: Drive continuous improvement initiatives to enhance quality systems, processes, and procedures, leveraging data-driven approaches and best practices.
• Communication: Serve as the primary point of contact for quality assurance-related matters, providing regular updates, reports, and presentations to senior management and stakeholders.

Qualifications:

• Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
• Minimum of 8-10 years of experience in quality assurance roles within the Pharma & Biotech industry, with at least 5 years in a director level position.
• In-depth knowledge of global regulatory requirements and guidelines for gene therapy products highly beneficial.
• Strong understanding of quality management systems (QMS), quality risk management principles, and Good Manufacturing Practices (GMP).
• Proven track record of successfully leading and managing quality assurance teams in biotech OR CDMO's.
• Excellent communication, interpersonal, and leadership skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
• Results-oriented mindset with a focus on continuous improvement and problem-solving.

Please apply directly or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io for further information.