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Empower Pharmacy

Senior Director, Quality Assurance

Empower Pharmacy, Houston, Texas, United States, 77246

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Position Summary 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.

Duties and Responsibilities Quality System Leadership

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.

AI-Driven Transformation

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.

Operational Excellence and Scalability

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.

Regulatory Strategy and Partnerships

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.

People and Culture

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.

Knowledge and Skills

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.

Key Competencies

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 works collaboratively with others to meet shared objectives.

Resourcefulness: Secures and deploys resources effectively and efficiently.

Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.

Ensures Accountability: Holds self and others accountable to meet commitments and objectives.

Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.

Communicates Effectively: Develops and delivers multi‑mode communications that convey a clear understanding of the unique needs of different audiences.

Values

People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.

Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.

Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.

Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications

Bachelor’s degree in a scientific, engineering, or related discipline; advanced degree preferred.

Minimum 15 years of progressive QA/QC leadership experience, with at least 7 in senior management.

Demonstrated success scaling quality systems in complex, high‑growth, or regulated environments.

Experience implementing AI or digital transformation in quality operations strongly preferred.

Exceptional leadership, communication, and organizational design skills.

Benefits We offer comprehensive benefits to support your health, well‑being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/

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