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Empower Pharmacy · 3 days ago

Director, Regulatory & Quality Policy

Houston, TX

Full-time

Onsite

Director/Executive

10+ years exp

Empower Pharmacy is committed to quality and compliance in compounding, and they are seeking a Director of Quality Advocacy. This role will strengthen the company's quality systems and represent Empower with regulators and policymakers while ensuring operational excellence and strategic advocacy in the sector.

Health CarePharmaceutical

Responsibilities

Build a unified, scalable quality blueprint integrating sterile and non-sterile operations across all sites

Strengthen enterprise risk identification through predictive controls, early warning systems, and data-driven governance

Maintain inspection-ready systems that reinforce documentation integrity and regulatory confidence

Develop predictive AI models to forecast deviations, detect anomalies, and reveal systemic risks

Implement automated quality controls and digital review-by-exception workflows to accelerate throughput

Build real-time intelligence dashboards integrating EM, batch, and process data for rapid, accurate decision-making

Engage policymakers, regulators, standard-setting bodies, coalitions, and trade associations to advance 503A/503B interests

Review, evaluate and propose state and federal legislation affecting compounding quality, safety, and compliance

Represent Empower through meetings, committees, working groups, conferences, and industry presentations that promote and defend 503A and 503B compounding

Provide quality subject-matter expertise to Government Affairs, Regulatory Affairs, Legal, and Quality teams

Support inspections, audits, and interactions with regulators and third-party auditors, ensuring aligned messaging and readiness

Support legal and regulatory proceedings, cases, and matters requiring technical quality interpretation

Use AI tools to monitor, predict, and interpret regulatory trends, legislative developments, and shifts in industry standards

Design scalable organizational structures and develop elite quality talent capable of high-velocity execution

Implement disciplined operating rhythms that drive alignment, transparency, and accountability enterprise-wide

Standardize site practices, accelerate issue resolution, and improve throughput reliability across locations

Qualification

Enterprise quality systemsAI/ML toolsRegulatory frameworksCompounding operationsMulti-site executionOptimizes work processesResourcefulnessManages complexityEnsures accountabilitySituational adaptabilityCustomer focusCollaboratesCommunicates effectively