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Empower Pharmacy · 9 hours ago

Senior Director, Quality Assurance

Houston, TX

Full-time

Onsite

Director/Executive

15+ years exp

Empower Pharmacy is seeking a Senior Director of Quality Assurance to lead the design and execution of their enterprise-wide Quality Assurance ecosystem. This role is responsible for ensuring that every product, process, and system meets world-class standards for safety, reliability, and compliance while integrating artificial intelligence to transform quality assurance.

Health CarePharmaceutical

H1B Sponsor Likely

Responsibilities

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

Qualification

CGMP regulationsFDA 503A/503B complianceAI/ML quality systemsData analyticsProcess automation toolsRegulatory inspectionsQuality system scalingExecutive communicationCross-functional influenceOptimizes work processesResourcefulnessManages complexityEnsures accountabilitySituational adaptabilityStrategic decision-makingCustomer focusCollaboratesCommunicates effectively

Required

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

Exceptional leadership, communication, and organizational design 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

Preferred

Experience implementing AI or digital transformation in quality operations strongly preferred

Benefits

Medical

Dental

Vision coverage

Paid time off

401(k) matching

Wellness perks

IV therapy

Compounded medications

Company

Empower Pharmacy

Glassdoor3.2

Compounding Pharmacy and Outsourcing Facility

Founded in 2009

Houston, Texas, USA

1001-5000 employees

http://empowerpharmacy.com/

H1B Sponsorship

Empower Pharmacy has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2020 (1)