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Director, Quality Assurance
Empower PharmacyDirector of Quality Assurance leading regulatory compliance and quality systems in pharmaceutical operations at Empower Pharmacy. Driving quality performance and inspection readiness in a fast-paced environment.
About the role
Key responsibilities & impact- Drives quality performance, regulatory compliance, and inspection readiness across Empower’s 503A and 503B operations.
- Owns quality systems, audit governance, supplier quality, validation oversight, and compliance execution supporting patient safety and business growth.
- Leverages AI-enabled analytics, predictive monitoring, and digital quality systems to improve decision-making, compliance visibility, and execution consistency.
- Leads Quality Assurance operations ensuring compliance with FDA regulations, cGMP requirements, and industry standards.
- Directs inspection readiness, including preparation, execution, and response management for audits.
- Oversees internal audit programs that assess quality systems and compliance.
- Directs supplier quality programs, including qualification, monitoring, and auditing across vendors.
- Provides leadership for validation activities including equipment, process, and system validation.
- Ensures adherence to FDA regulations, USP standards, and cGMP practices.
- Oversees deviations, investigations, CAPAs, and change controls.
- Leads risk management efforts to identify compliance vulnerabilities and operational gaps.
- Partners cross-functionally to integrate quality requirements into business processes.
- Establishes KPIs to monitor quality performance and compliance trends.
- Drives initiatives improving quality systems and operational efficiency.
- Builds high-performing quality teams that foster accountability and continuous improvement.
- Aligns quality priorities with executive and cross-functional teams.
- Provides updates on quality performance and compliance risks.
Requirements
What you’ll need- 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.
- Proven ability to lead teams and drive measurable quality and compliance outcomes.
- Lean Six Sigma Green Belt, Certified Pharmaceutical Industry Professional (CPIP), Professional Engineer (PE), or Certified Quality Engineer (CQE) certification preferred.
Benefits
Comp & perks- Medical, dental, and vision coverage
- Paid time off
- 401(k) matching
- Wellness perks
- IV therapy
- Compounded medications