Senior Director, Quality & Regulatory Excellence

Gift of Life Marrow Registry; Boca Raton (FL); On-site; USD 150,000 - 190,000; Full time

Job summary

Gift of Life Marrow Registry seeks a Director of Quality and Compliance to lead the organization’s QA and regulatory programs. The role ensures the product/service meets customer expectations and regulatory standards while guiding policy, training, and continuous quality improvement.

Responsibilities include maintaining accreditations, overseeing QA systems, and coordinating with leadership to pass regulatory inspections and uphold industry best practices in cell and gene therapy environments.

Qualifications

• Bachelor’s degree in biology, biochemistry or related field required.
• Minimum 10 years of biopharmaceutical quality assurance experience with QA systems, FDA, cGMPs, and ATMP regulations.
• At least 5 years’ QA experience in cell and gene therapy or biologics manufacturing.
• Experience obtaining and maintaining FACT accreditation.
• Strong leadership, mentoring and staff development capabilities.

Responsibilities

• Oversee quality system requirements to ensure compliance with FDA and state regulatory standards and accrediting bodies.
• Keep abreast of laws and regulations affecting policies via industry sources and seminars.
• Collaborate with Associate Director to ensure smooth QA department operations.
• Work with departmental directors to apply for relevant accreditations.
• Maintain current and future accreditations and certifications.
• Provide training across the organization on quality and regulatory issues.
• Promote quality achievement and performance improvement throughout the organization.
• Enforce QA compliance objectives and ensure targets are met.
• Perform other duties as assigned.

Skills

Quality systems

FDA knowledge

GMP

Leadership

Staff training

English communication

Process improvement

Regulatory inspections

Education

Bachelor’s degree in biology, biochemistry or related scientific field

Job description

Gift of Life Marrow Registry seeks a Director of Quality and Compliance to lead the organization’s QA and regulatory programs. The role ensures the product/service meets customer expectations and regulatory standards while guiding policy, training, and continuous quality improvement.

Responsibilities include maintaining accreditations, overseeing QA systems, and coordinating with leadership to pass regulatory inspections and uphold industry best practices in cell and gene therapy environments.