Senior Director, Quality & Compliance (Biopharma)

Gift-of-Life-Marrow-Registry-Inc.; Boca Raton (FL); On-site; USD 130,000 - 190,000; Full time

Job summary

Evolving Solution Services in Boca Raton, FL is seeking a Director of Quality and Compliance to lead the QA program and ensure regulatory compliance for biopharmaceutical products across all operations, including manufacturing and QA documentation.

The ideal candidate will have 10+ years in QA for biopharma, strong knowledge of FDA, cGMPs, and ATMP regulations, plus proven leadership and staff development abilities.

Qualifications

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

Responsibilities

• Oversee QA system requirements to ensure compliance with FDA and state health regulations and accrediting bodies.
• Keeps abreast of laws and regulations via industry bulletins, journals, meetings and seminars.
• Works with Associate Director to ensure smooth daily operations within the QA department.
• Works with departmental directors to apply for relevant accreditations in the industry.
• Maintains organization’s existing and future accreditations and certifications.
• Provides training across the organization regarding applicable quality and regulatory issues.
• Promotes quality achievement and performance improvement throughout the organization.
• Enforces QA compliance objectives and ensures that targets are achieved.
• Other duties as assigned.

Skills

Quality assurance

FDA compliance

Leadership

Regulatory inspections

cGMPs

ATMP regulations

Quality systems

Cell therapy

Documentation

Training

Communication

Education

Bachelor's degree in biology/biochemistry

Tools

Regulatory databases

Job description

Evolving Solution Services in Boca Raton, FL is seeking a Director of Quality and Compliance to lead the QA program and ensure regulatory compliance for biopharmaceutical products across all operations, including manufacturing and QA documentation.

The ideal candidate will have 10+ years in QA for biopharma, strong knowledge of FDA, cGMPs, and ATMP regulations, plus proven leadership and staff development abilities.