What are the responsibilities and job description for the Director, Quality Advocacy position at Empower Pharmacy?
Position Summary:
Values
The Director of Quality Advocacy strengthens Empower’s enterprise quality backbone while serving as the organization’s leading external advocate for quality, safety, and compliance in 503A and 503B compounding. This role integrates deep operational expertise with strategic policy influence, ensuring Empower’s quality systems scale predictively, operate inspection-ready, and reflect industry-leading precision. Internally, the Director architects quality frameworks, deploys AI-driven intelligence, unifies multi-site execution, and builds a high-performance organization capable of supporting rapid growth. Externally, the Director represents Empower with regulators, policymakers, standard-setting bodies, advocacy groups, and industry coalitions—educating stakeholders, shaping legislation, and strengthening Empower’s position as a trusted national leader. This leader supports regulatory interactions, inspections, legal and compliance matters, and contributes expertise to committees and industry forums. By combining operational excellence with strategic advocacy, the Director ensures Empower protects patients, accelerates outcomes, and influences the future landscape of compounding.
Duties and Responsibilities:
Enterprise Quality Architecture & Risk Leadership
- 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.
AI-Driven Quality Transformation
- 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.
Advocacy, Policy Influence & External Representation
- 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.
Regulatory, Legal & Government Affairs Partnership
- 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.
Team Leadership, Culture Building & Multi-Site Execution
- 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.
- Expertise in enterprise quality systems, compounding operations, and regulatory frameworks, with strong ability to translate technical concepts for policymakers and cross-functional stakeholders.
- Advanced capability in deploying AI/ML tools for predictive analytics, risk modeling, automated workflows, and real-time operational intelligence.
- Deep understanding of federal and state regulatory landscapes, legislative processes, and external advocacy strategies within healthcare or similarly regulated industries.
- Proven ability to architect organizations, build high-performance teams, and lead multi-site execution in fast-growth, high-complexity 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.
- 10 years in quality, regulatory, operations, government affairs, or related leadership roles within regulated industries.
- Demonstrated success building enterprise systems, scaling organizations, and leading multi-site quality functions.
- Experience engaging policymakers, regulators, industry associations, and external stakeholders.
- Experience representing a company in legislative, regulatory, or policy-focused forums strongly preferred.
- Strong background in inspections, audits, regulatory interactions, and support for legal/regulatory matters.
- Bachelor’s degree required; advanced degree preferred.
- Proven ability to apply AI-driven insights to improve quality, predict risk, and influence enterprise decisions.
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/