Location: Houston, TX - Hybrid
Posted: February 24, 2026
Job Type: Full Time
Req# 2026-5494
Legal
Position Summary
The Senior Regulatory & Compliance Pharmacist (503B) safeguards and accelerates Empower's enterprise regulatory performance by architecting scalable, AI-enabled compliance systems that withstand hyper growth. This role owns FDA inspection readiness, 483 defense strategy, CAPA durability, regulatory submissions, and deviation rigor across facilities. Success means zero preventable repeat findings, measurable reduction in inspection severity, accelerated submission cycle times, and quality systems that scale ahead of production volume. The role converts evolving FDA expectations into disciplined operational infrastructure, integrating predictive analytics, AI-assisted drafting, automated compliance dashboards, and risk modeling to strengthen execution speed and decision precision. As a senior individual contributor, this leader drives end-to-end regulatory initiatives with minimal oversight, installs structured operating systems, and ensures regulatory strategy enables expansion rather than constrains it. This position directly protects licensure, patient safety, and revenue continuity while positioning Empower as the industry benchmark for 503B regulatory excellence.
Duties and Responsibilities
Enterprise FDA Inspection Leadership
• Design and maintain enterprise-wide FDA inspection readiness architecture, including mock audits, risk dashboards, and AI-driven gap analysis tools.
• Lead FDA 483 response strategy, ensuring systemic corrections, validated commitments, and durable execution under production pressure.
• Analyze industry warning letters and enforcement trends using AI synthesis to eliminate repeat findings and preempt regulator focus areas.
Scalable Quality Systems & CAPA Architecture
• Architect data-driven root cause investigation frameworks distinguishing systemic failures from human error.
• Enforce CAPA durability through measurable success criteria, leading indicators, and AI-supported effectiveness tracking.
• Conduct regulator-depth internal audits across sterile operations, documentation control, and training systems, driving verified closure.
Regulatory Strategy & Growth Enablement
• Accelerate submission cycles through structured templates, AI-assisted drafting, and validation checkpoints reducing revision cycles.
• Integrate regulatory risk assessments into facility expansions, capacity increases, and process changes.
• Quantify regulatory exposure through enterprise dashboards translating compliance risk into business impact metrics.
AI-Enabled Compliance Transformation
• Deploy AI tools to synthesize FDA guidance updates and internal deviation trends into structured risk insights.
• Implement automated compliance monitoring systems replacing manual spreadsheets with real-time performance dashboards.
• Develop predictive risk models using historical inspection data to forecast and prevent emerging compliance vulnerabilities.
Enterprise Impact & Operating Systems
• Own complex regulatory initiatives end-to-end with defined scope, timelines, and measurable outcomes.
• Install elite operating rhythms including weekly risk reviews, decision logs, and execution dashboards.
• Build reusable templates, crosswalks, and response frameworks that create compounding regulatory leverage.
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
• Deep expertise in FDA 503B regulations, cGMP requirements, sterile compounding operations, inspection management, and regulatory submission strategy, with ability to translate guidance into scalable operational systems.
• Advanced proficiency using AI tools for regulatory intelligence synthesis, drafting precision, predictive risk modeling, and automation of compliance monitoring workflows.
• Strong analytical capabilities in deviation trending, root cause analysis, CAPA effectiveness validation, and enterprise risk quantification using structured data dashboards.
• Demonstrated ability to design SOP architecture, audit programs, and scalable quality infrastructure in high-growth, multi-site pharmaceutical environments.
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
• Doctor of Pharmacy (PharmD) required
• 7+ years of progressive regulatory, quality, or compliance experience in 503B outsourcing facilities or cGMP-regulated pharmaceutical manufacturing.
• Inspections, 483 response strategy, CAPA systems, and regulatory submissions.
• Proven experience implementing scalable systems in high-growth, multi-site operations.
• Experience leveraging AI tools or advanced analytics to improve regulatory execution speed and quality strongly preferred.
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/