Head of Quality

Overview

The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.

What You Will Do

• Provide strategic and operational leadership to establish, improve, and maintain the quality systems, policies, standards, and procedures.
• Ensure compliance with current US FDA, EMA, and relevant ICH guidance documents.
• Ensure the Quality Organization is appropriately resourced and effectively executing a required state of quality and CGMP compliance.
• Manage all quality oversight activities related to internal and external manufacturing, contract release and stability testing, and raw material suppliers.
• Achieve both quality and business objectives for the organization by developing short and long-term plans.
• Achieve quality policies and objectives by ensuring they are clearly communicated, implemented, and maintained within the organization.
• Ensure manufacturing, testing and release, and distribution of gene therapy products are consistent and meet all relevant regulatory requirements.
• Develop quality metrics and indicators to proactively identify and address quality systems or product-related issues.
• Lead a Quality Management Review (QMR) process to ensure continued compliance with CGMP standards.
• Interface directly with the FDA, EMA, other regulatory authorities, and customer clients to ensure the company is appropriately represented in all matters related to compliance and quality.
• Exercise discretion, judgment, and personal responsibility. Demonstrate a high level of integrity. Maintain a positive attitude. Perform in accordance with established policies, procedures, and techniques.
• Mentor and professional development of staff.
• Establish a strategic process to control work procedures.
• Complete budgetary control over the functions under their control also influencing organizational budget establishment.
• Some travel is required.
• Hire, develop, and related personnel processes.
• Develop and define measurable objectives for the staff within their functional units to fit the objectives of the overall organization.
• Develop and direct short and near-term goals.
• Responsible for developing a 3–5-year business plan.
• Responsible for Revenue (P&L).
• Interpret regulations for application within their functional unit.
• Consider business impacts in planning and problem-solving.
• Responsible for business development.

Requirements

• Possess a relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred.
• Have expert business knowledge with a comprehensive understanding of the organizational and functional areas.
• Have advanced leadership skills.
• Have excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Be highly skilled in Microsoft Office (PowerPoint, Excel, Word), including data interpretation and reporting.
• Be able to work independently as well as collaboratively in a diverse and inclusive work environment.
• Have a client-focused mindset in daily tasks.
• Have prior experience handling confidential information and the ability to maintain confidentiality.