Director, Innovation & PMO
Location
United States
Posted
3 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Director, Innovation & PMO
Empower Pharmacy
Role Description 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. - Ensures that company operations consistently meet mandated standards. - Proactively identifies gaps, mitigates risk, and prevents repeat deviations. - Strengthens organizational readiness for inspections. - Supports sustained regulatory alignment by embedding compliant practices into daily operations. - Success is measured by audit accuracy, reduction in compliance deviations, and reliability of systems. Responsibilities - Compliance Operations & Project Coordination: - Coordinate and track cross-functional compliance initiatives. - Support the implementation and maintenance of compliance programs. - Assist in translating regulatory requirements into actionable tasks. - Regulatory Monitoring & Documentation Management: - Maintain current awareness of applicable Federal and State regulations. - Maintain an organized, inspection-ready compliance library. - Support controlled document management processes. - Inspection Readiness & Audit Support: - Support inspection readiness activities. - Assist in retrieving and organizing requested records during inspections. - Track and trend audit observations and compliance metrics. - Licensing & Compliance Tracking: - Monitor employee licensure and certification statuses. - Track facility licenses, permits, and renewals. - Provide administrative and project support to the licensing function. - Regulatory Communication & Cross-Functional Support: - Assist in drafting and distributing client-facing and internal communications. - Coordinate compliance-related training logistics. - Collaborate with internal teams to ensure consistent understanding of compliance expectations. - General Support & Operational Flexibility: - Provide administrative support for compliance-related initiatives. - May assist at alternate Empower locations as business needs require. - Perform additional duties as assigned to support the compliance program. - Contribute to reporting dashboards and summaries. - AI-Enabled Compliance & Scalable Impact: - Deploy AI tools to accelerate regulatory research and drafting. - Implement automated dashboards tracking compliance metrics. - Apply predictive modeling to historical data to reduce compliance volatility. Qualifications - Working knowledge of 503A and 503B regulatory frameworks. - Experience supporting compliance activities such as internal audits. - Ability to assist in drafting regulatory responses and tracking CAPAs. - Familiarity with leveraging technology, including AI tools. - Detail-oriented with a process-driven mindset. 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. Benefits - Comprehensive medical, dental, and vision coverage. - Paid time off. - 401(k) matching. - Wellness perks. - IV therapy and compounded medications. Physical Requirements - Required to talk and hear. - Often required to remain in a stationary position for a significant amount of the workday. - Frequently use hands and fingers to handle or feel. - Regularly required to move about the office and corporate campus. - Regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
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