Director, Quality & FDA Compliance – Sterile Pharmacy

Optimal Balance Pharmacy; Houston (TX); On-site; USD 90,000 - 140,000; Full time

Job summary

Optimal Balance Pharmacy seeks a Director of Quality & FDA Compliance to build and lead the Quality and regulatory infrastructure required to support our next stage of national growth.

This senior leader will drive FDA inspection readiness, CAPA, investigations, and a scalable QMS across sterile compounding and 503A operations, partnering with executives to ensure patient safety and compliant expansion.

Qualifications

• Senior leader with firsthand FDA-regulated pharma experience.
• Experience with FDA inspections, readiness, and 483 responses.
• Capability to build scalable quality systems for national growth.

Responsibilities

• Own FDA and regulatory inspection readiness, including documentation and training.
• Lead investigations, CAPAs, deviations, and change controls.
• Develop and manage a robust Quality Management System (QMS).
• Oversee environmental monitoring, sterility assurance, and validation programs.
• Interface with executive leadership on compliance risk and remediation strategies.

Skills

FDA-regulated manufacturing

Sterile manufacturing

503B outsourcing

Sterile compounding

CDMO operations

Regulatory compliance

Quality management systems

Regulatory inspections

CAPA investigations

Root-cause analysis

Education

Bachelor’s degree in pharmacy or related scientific field

Job description

Optimal Balance Pharmacy seeks a Director of Quality & FDA Compliance to build and lead the Quality and regulatory infrastructure required to support our next stage of national growth.

This senior leader will drive FDA inspection readiness, CAPA, investigations, and a scalable QMS across sterile compounding and 503A operations, partnering with executives to ensure patient safety and compliant expansion.