Director of AI-Enabled Quality & Compliance

Quality Search Personal GmbH; Houston (TX); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

401(k) matching

Wellness perks

IV therapy

Compounded medications

Job summary

Empower Pharmacy is a leading healthcare company focused on advancing quality and access to medications. The Director, Quality Assurance drives regulatory compliance and inspection readiness across 503A and 503B operations, overseeing quality systems, supplier quality, validation, and governance, leveraging AI-enabled analytics to improve decision-making and execution.

This role requires strategic thinking, leadership in a hyper-growth, regulated environment, and a proven track record in

Qualifications

• Bachelor's degree in scientific or technical discipline required.
• Minimum 10 years of pharmaceutical quality experience, including regulatory inspection leadership.
• Experience overseeing quality systems, supplier quality, validation, and compliance programs.
• Experience implementing digital quality systems and process improvements preferred.

Responsibilities

• Leads Quality Assurance operations ensuring compliance with FDA regulations, cGMP, and standards.
• Directs inspection readiness, including audits and response management.
• Oversees internal audit programs, CAPA, and continuous improvement initiatives.
• Directs supplier quality programs, including qualification, monitoring, and auditing.
• Provides leadership for validation activities including equipment, process, and system validation.

Skills

Quality Assurance

FDA regulations

cGMP

Audit governance

Supplier quality

Validation

Regulatory compliance

AI analytics

Leadership

Quality systems

Education

Bachelor's degree in scientific or technical discipline

Tools

AI analytics tools

Job description

Empower Pharmacy is a leading healthcare company focused on advancing quality and access to medications. The Director, Quality Assurance drives regulatory compliance and inspection readiness across 503A and 503B operations, overseeing quality systems, supplier quality, validation, and governance, leveraging AI-enabled analytics to improve decision-making and execution.

This role requires strategic thinking, leadership in a hyper-growth, regulated environment, and a proven track record in