Senior Director, Quality Assurance

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The Senior Director of Quality Assurance leads the design and execution of Empower Pharmacy’s enterprise-wide Quality Assurance ecosystem. This role ensures that every product, process, and system meets world‑class standards for safety, reliability, and compliance while integrating artificial intelligence to transform quality assurance. The leader will architect scalable systems that enable predictive compliance, flawless documentation, and continuous process improvement across QA, QC, and regulatory functions.

Working cross‑functionally with Manufacturing, Operations, Quality Operations, Quality Control, and Regulatory Affairs, the Senior Director ensures Empower is always at inspection‑ready excellence. The ideal candidate combines strategic foresight with operational mastery—someone who can lead through rapid growth, inspire high‑performance teams, and embed quality as a competitive advantage across the organization.

• Architect and govern an integrated Quality Management System aligned with FDA 503A/503B, cGMP, and ISO standards.
• Architect a system for addressing and preventing customer complaints across the Enterprise.
• Ensure GXP training is timely, compliant, and effective.
• Maintain continuous audit readiness and regulatory confidence through system integrity and transparent documentation.

• Deploy machine learning to detect anomalies, streamline CAPA, and forecast quality risks.
• Integrate smart data platforms uniting lab, manufacturing, and compliance intelligence.
• Leverage AI for audit simulation, inspection preparedness, and continuous process optimization.

• Engineer scalable QA frameworks that adapt to new products, volumes, and geographies.
• Define and cascade proactive quality KPIs to drive performance accountability.
• Modernize digital QA infrastructure for interoperability, speed, and traceability.

• Cultivate trusted relationships with FDA, DEA, and state boards through transparency and consistency.
• Lead major regulatory inspections with composure, authority, and mastery of compliance detail.
• Translate emerging regulatory trends into business advantage through agile adaptation.

• Design a high‑velocity, future‑ready QA organization that thrives under autonomy and accountability.
• Recruit and develop top 1 % quality professionals who combine scientific rigor with operational agility.
• Foster a culture of excellence, feedback, and innovation driven by mission and measurable impact.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus.

The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

• Expert understanding of cGMP, FDA 503A/503B regulations, and global quality system standards.
• Demonstrated proficiency in AI/ML‑enabled quality systems, data analytics, and process automation tools.
• Proven ability to lead large‑scale transformations in regulated manufacturing or healthcare environments.
• Strong executive communication, cross‑functional influence, and strategic decision‑making capability.

• Customer Focus:
  Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes:
  Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates:
  Builds partnerships and…