Empower Pharmacy
Director, Government Affairs - Quality Policy and Regulatory Affairs
Empower Pharmacy, Houston, Texas, United States, 77246
Director, Government Affairs - Quality Policy and Regulatory Affairs
Position Summary. The Director of Government Affairs, Quality Policy and Regulatory Affairs serves as Empower’s subject matter expert on all federal and state laws, regulations, and standards governing 503A compounding pharmacies and 503B outsourcing facilities. This leader drives Empower’s engagement with regulators, legislators, and standards organizations to ensure alignment between business priorities and evolving policy landscapes. Combining regulatory expertise with data-driven foresight, the Director transforms compliance into a strategic advantage—using AI-powered intelligence to anticipate regulatory change, influence quality policy, and shape the national dialogue on compounding. Working cross-functionally with Quality, Compliance, Legal, and Operations teams, this position ensures Empower not only meets but defines the standards of excellence in pharmacy manufacturing and patient safety.
Duties and Responsibilities
Serve as Empower’s authority on all quality-related regulations, policies, and standards impacting 503A and 503B operations.
Lead interpretation and communication of complex regulatory language, providing actionable insights to executive leadership.
Develop unified quality policy frameworks harmonizing USP and CGMP requirements.
Represent Empower before FDA, USP, DEA, NABP, and state boards to influence standards and advocate for data-driven policy.
Draft and present policy language, comment letters, and position papers advancing the science and safety of compounding.
Build relationships with policymakers, regulators, and key opinion leaders to drive shared outcomes in public health.
Deploy AI and machine learning tools to monitor legislation, FDA actions, and enforcement patterns, predicting impact on Empower’s operations.
Use advanced analytics to identify compliance risks, recommend policy responses, and enhance audit readiness.
Integrate AI insights into decision dashboards that inform leadership strategy and advocacy priorities.
Partner with Quality, Legal, Compliance, and Operations to translate evolving regulations into operational processes and SOPs.
Facilitate executive briefings on emerging policy trends, ensuring readiness and unified enterprise response.
Embed regulatory foresight into Empower’s business planning, facility expansion, and product development strategies.
Develop and publish white papers, policy briefs, and educational materials supporting Empower’s leadership in quality and compliance.
Speak at national conferences, hearings, and forums to articulate Empower’s vision for responsible innovation in pharmacy.
Mentor emerging regulatory and policy leaders, cultivating expertise and alignment across the organization.
Knowledge and Skills
Deep expertise in FDA, DEA, USP, and state pharmacy regulations governing 503A and 503B facilities.
Proven ability to lead policy strategy and advocacy through data-driven insights and evidence-based reasoning.
Skilled in leveraging AI tools for regulatory forecasting, compliance analytics, and legislative intelligence.
Exceptional communication and leadership skills, capable of influencing at the intersection of science, law, and business.
Experience and Qualifications
Advanced degree (PharmD, JD, or equivalent) preferred.
10+ years in regulatory affairs, government affairs, or quality policy leadership within healthcare, life sciences, or related sectors.
Demonstrated success influencing policy or regulation at federal and state levels.
Expertise in CGMP, USP, and compounding guidance preferred.
Experience using AI or data tools for regulatory analysis and strategic decision-making.
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
Optimizes Work Processes: Effective processes for 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 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.
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.
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/
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Duties and Responsibilities
Serve as Empower’s authority on all quality-related regulations, policies, and standards impacting 503A and 503B operations.
Lead interpretation and communication of complex regulatory language, providing actionable insights to executive leadership.
Develop unified quality policy frameworks harmonizing USP and CGMP requirements.
Represent Empower before FDA, USP, DEA, NABP, and state boards to influence standards and advocate for data-driven policy.
Draft and present policy language, comment letters, and position papers advancing the science and safety of compounding.
Build relationships with policymakers, regulators, and key opinion leaders to drive shared outcomes in public health.
Deploy AI and machine learning tools to monitor legislation, FDA actions, and enforcement patterns, predicting impact on Empower’s operations.
Use advanced analytics to identify compliance risks, recommend policy responses, and enhance audit readiness.
Integrate AI insights into decision dashboards that inform leadership strategy and advocacy priorities.
Partner with Quality, Legal, Compliance, and Operations to translate evolving regulations into operational processes and SOPs.
Facilitate executive briefings on emerging policy trends, ensuring readiness and unified enterprise response.
Embed regulatory foresight into Empower’s business planning, facility expansion, and product development strategies.
Develop and publish white papers, policy briefs, and educational materials supporting Empower’s leadership in quality and compliance.
Speak at national conferences, hearings, and forums to articulate Empower’s vision for responsible innovation in pharmacy.
Mentor emerging regulatory and policy leaders, cultivating expertise and alignment across the organization.
Knowledge and Skills
Deep expertise in FDA, DEA, USP, and state pharmacy regulations governing 503A and 503B facilities.
Proven ability to lead policy strategy and advocacy through data-driven insights and evidence-based reasoning.
Skilled in leveraging AI tools for regulatory forecasting, compliance analytics, and legislative intelligence.
Exceptional communication and leadership skills, capable of influencing at the intersection of science, law, and business.
Experience and Qualifications
Advanced degree (PharmD, JD, or equivalent) preferred.
10+ years in regulatory affairs, government affairs, or quality policy leadership within healthcare, life sciences, or related sectors.
Demonstrated success influencing policy or regulation at federal and state levels.
Expertise in CGMP, USP, and compounding guidance preferred.
Experience using AI or data tools for regulatory analysis and strategic decision-making.
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
Optimizes Work Processes: Effective processes for 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 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.
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.
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/
#J-18808-Ljbffr