Senior QA Auditor – Pharma Compliance & Supplier Risk

Empower Pharmacy; Houston (TX); On-site; USD 100,000 - 130,000; Full time

Job summary

Empower Pharmacy in Houston, TX is seeking a Senior Quality Assurance Specialist to strengthen site quality oversight, drive inspection readiness, and ensure supplier reliability in a fast-growing, highly regulated 503A/503B environment.

You will lead complex audits, coordinate external assessments, and advance risk-based qualification and monitoring of critical suppliers, while coaching cross-functional teams to sustain cGMP adherence and continuous quality improvements.”

Qualifications

• At least 5 years of quality experience within pharmaceutical manufacturing, with a strong understanding of cGMP requirements and regulatory compliance required.
• A bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline, or equivalent work experience demonstrating relevant quality expertise required.
• Experience leading audits or inspection preparation, coordinating cross-functional responses, and following corrective actions through implementation and documented verification of effectiveness required.
• Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA) certification relevant to auditing and quality improvement responsibilities strongly preferred.

Responsibilities

• Lead preparation and execution for regulatory inspections, customer audits, and external assessments, coordinating subject-matter experts, accurate responses, and timely commitment completion.
• Develop risk-based internal audit plans, lead complex audits, evaluate systemic compliance risks, and prepare reports documenting findings and required actions.
• Lead risk-based qualification, auditing, and approval of critical suppliers and service providers, evaluating capabilities, compliance history, and business and patient risks.
• Evaluate root-cause analyses and corrective action plans, oversee implementation, and verify effectiveness to support sustainable resolution of audit findings and supplier issues.
• Review quality documentation for accuracy and completeness, using batch record knowledge and Microsoft Office tools to support audit preparation and reporting.
• Deliver training and coaching on compliance gaps and remediation requirements, strengthening cross-functional understanding, execution discipline, and accountability for commitments.

Skills

cGMP compliance

Regulatory compliance

Auditing

Root cause analysis

Documentation

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

Empower Pharmacy in Houston, TX is seeking a Senior Quality Assurance Specialist to strengthen site quality oversight, drive inspection readiness, and ensure supplier reliability in a fast-growing, highly regulated 503A/503B environment.

You will lead complex audits, coordinate external assessments, and advance risk-based qualification and monitoring of critical suppliers, while coaching cross-functional teams to sustain cGMP adherence and continuous quality improvements.”