Job Description

Rx Group is recruiting for a Head of QC to join a late phase gene therapy biotech for an on-site position in Florida.

Key Responsibilities:

• Leadership: Provide strategic direction and leadership to the QC team, fostering a culture of excellence, collaboration, and continuous improvement.
• Team Management: Recruit, develop, and mentor a high-performing QC team, ensuring adequate staffing and training to support departmental objectives.
• QC Operations: Oversee all QC activities related to Microbiology and Analytical testing, including method development, validation, and transfer.
• Compliance: Ensure adherence to regulatory requirements and industry standards (e.g., FDA, EMA, ICH) in QC operations, documentation, and reporting.
• Quality Systems: Establish and maintain robust quality systems to support QC operations, including SOPs, protocols, specifications, and investigations.
• Technology Transfer: Lead the transfer of analytical methods and technologies from development to QC, ensuring seamless integration and implementation.
• Risk Management: Identify and mitigate risks related to QC operations, ensuring product quality and patient safety throughout the product lifecycle.
• Cross-Functional Collaboration: Collaborate closely with other departments, including Manufacturing, Quality Assurance (QA), Regulatory Affairs, and R&D, to support overall business objectives and project timelines.
• Continuous Improvement: Drive continuous improvement initiatives within the QC function, implementing best practices and innovative technologies to enhance efficiency and effectiveness.
• Communication: Communicate QC strategy, progress, and issues effectively to senior management and key stakeholders, providing regular updates and recommendations.

Qualifications:

• Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Microbiology); advanced degree (e.g., Master's or Ph.D.) preferred.
• Minimum of 8-10 years of experience in pharmaceutical or biotech QC, with at least 5 years in a QC leadership role.
• Extensive knowledge of QC principles, methodologies, and regulatory requirements applicable to gene therapy products.
• Strong technical expertise in Microbiology and Analytical testing techniques, including PCR, ELISA, HPLC, and other relevant assays.
• Experience with quality systems (e.g., GMP, GLP) and regulatory inspections (e.g., FDA, EMA).
• Proven track record of successfully managing and developing high-performing QC teams in a fast-paced environment.
• Excellent leadership, communication, and problem-solving skills, with the ability to influence and collaborate effectively across functions.
• Detail-oriented mindset with a strong commitment to quality, compliance, and patient safety.

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