Director, Innovation & PMO at Empower Pharmacy

, , United States -

Full Time

Start Date

Immediate

Expiry Date

16 Oct, 26

Salary

0.0

Posted On

18 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Audit Coordination, Documentation Management, CAPA Tracking, AI Tool Deployment, Risk Mitigation, Project Coordination, Licensing Management, Root Cause Analysis, SOP Maintenance, Cross-functional Collaboration, Regulatory Research

Industry

Pharmaceutical Manufacturing

Description

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation’s most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we’re redefining what’s possible in personalized medicine and pharmaceutical manufacturing. We’re proud to be recognized as one of Houston’s fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025. Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we’ve created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that’s transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let’s transform healthcare together. Position Summary: The Compliance Coordinator operates as a key driver in the execution, integrity, and continuous improvement of Empower’s compliance infrastructure. Under the direction of the Pharmacist in Charge, this role partners with Compliance Specialists to ensure rigorous adherence to regulatory frameworks governing compounding pharmacy, including DEA, FDA, USP, and State Board of Pharmacy requirements. Accountable for auditing, monitoring, and reinforcing procedural compliance, this individual ensures that company operations consistently meet mandated standards while proactively identifying gaps, mitigating risk, and preventing repeat deviations. The role strengthens organizational readiness for inspections and supports sustained regulatory alignment by embedding compliant practices into daily operations. Success in this position is measured by audit accuracy, reduction in compliance deviations, and the reliability of systems that uphold legal and procedural integrity. This role does not simply support compliance—it reinforces and operationalizes the standards that protect Empower’s licensure, reputation, and ability to scale within a highly regulated environment. Resposibilities: Compliance Operations & Project Coordination Coordinate and track cross-functional compliance initiatives, ensuring timelines, deliverables, and documentation align with regulatory requirements and organizational priorities. Support the implementation and maintenance of compliance programs across 503A and 503B operations, reinforcing adherence to established procedures, workflows, and internal controls. Assist in translating regulatory requirements into actionable tasks, ensuring consistent execution and follow-through across departments. Regulatory Monitoring & Documentation Management Maintain current awareness of applicable Federal and State regulations, including FDA, DEA, USP, and State Board of Pharmacy requirements, and communicate relevant updates to internal stakeholders. Maintain an organized, inspection-ready compliance library, including licenses, permits, SOPs, training records, vendor documentation, audit reports, and CAPA records. Support controlled document management processes, ensuring accurate versioning, accessibility, and archival in accordance with company standards. Inspection Readiness & Audit Support Support inspection readiness activities by coordinating mock audits, tracking readiness metrics, and ensuring documentation is complete and accessible. Assist in retrieving and organizing requested records during regulatory inspections and internal audits. Track and trend audit observations, deviations, and compliance metrics, escalating recurring issues to leadership for further evaluation. Licensing & Compliance Tracking Monitor employee licensure and certification statuses, ensuring all credentials remain current and notifying individuals and leadership of upcoming expirations. Track facility licenses, permits, and renewals, supporting timely submissions and maintaining continuity of operations. Provide administrative and project support to the licensing function as needed. Regulatory Communication & Cross-Functional Support Assist in drafting and distributing client-facing and internal communications related to regulatory updates, including FDA guidance, USP standards, and State Board requirements. Coordinate compliance-related training logistics, documentation, and recordkeeping to support organizational readiness. Collaborate with internal teams to ensure consistent understanding and application of compliance expectations. General Support & Operational Flexibility Provide administrative support for compliance-related initiatives, meetings, and reporting activities. May assist at alternate Empower locations as business needs require. Perform additional duties as assigned to support the compliance program and organizational objectives. Contribute to reporting dashboards and summaries that provide visibility into compliance performance and risk areas. AI-Enabled Compliance & Scalable Impact Deploy AI tools to accelerate regulatory research, drafting, and cross-functional translation. Implement automated dashboards tracking license renewals, CAPAs, audit findings, and inspection readiness metrics. Apply predictive modeling to historical inspection and deviation data to proactively reduce compliance volatility. Knowledge and Skills: Working knowledge of 503A and 503B regulatory frameworks, USP 795/797/800 standards, FDA guidance, DEA requirements, and State Board of Pharmacy regulations as applicable to compounding pharmacy operations. Experience supporting compliance activities such as internal audits, documentation review, and maintaining adherence to established procedures and regulatory expectations. Ability to assist in drafting regulatory responses, tracking corrective and preventive actions (CAPAs), and contributing to root cause analysis efforts under leadership guidance. Familiarity with leveraging technology, including AI tools, to support regulatory research, streamline documentation, and enhance accuracy and efficiency in compliance-related tasks. Detail-oriented with a process-driven mindset, contributing to the maintenance and continuous improvement of SOPs, compliance tracking tools, and training support initiatives that promote consistent regulatory adherence. Key Competencies: Customer Focus: Builds trust through customer-centric solutions. Strategic AI: Guides responsible AI adoption and adaptation. Optimizes Work Processes: Drives efficiency with continuous improvement. Collaborates: Partners effectively to achieve shared goals. Resourcefulness: Secures and deploys resources efficiently. Manages Complexity: Simplifies and solves complex challenges. Ensures Accountability: Delivers on commitments with integrity. Situational Adaptability: Adjusts approach to shifting conditions. Communicates Effectively: Tailors messages to diverse audiences. Values: People: Empowering people defines who we are. Quality: Excellence in every product, every time. Service: Serving others is our highest purpose. Innovation: Advancing care through technology and discovery. Employee Benefits, Health and Wellness: 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/ Physical Requirements: 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.

Responsibilities

The role coordinates and executes compliance infrastructure to ensure adherence to DEA, FDA, USP, and State Board of Pharmacy requirements. It involves managing documentation, supporting inspection readiness, and utilizing AI tools to streamline regulatory research and tracking.