Empower Pharmacy
Senior Manager, Controlled Substance Compliance
Empower Pharmacy, Houston, Texas, United States, 77246
Location:
Houston, TX
Posted:
September 23, 2025
Job Type:
Full Time
Req#
2025-5158
Legal
Position Summary
The Senior Manager, Controlled Substance Compliance at Empower Pharmacy is entrusted with ensuring the highest standards of regulatory alignment and integrity in the handling of controlled substances. Reporting to the Director, Controlled Substance Compliance, this leader plays a critical role in protecting patient safety and advancing Empower's mission to expand access to safe, high-quality, and affordable medication. With Empower manufacturing more than 300 million doses annually as the nation's largest 503A compounding pharmacy and an FDA-registered 503B outsourcing facility, this position is central to maintaining trust with regulators, patients, and providers.
Duties and Responsibilities
Ensures strict adherence to DEA, FDA, and state board regulations governing the procurement, receiving, storage, dispensing, reconciliation, and disposal of controlled substances across Empower operations. Develops, implements, and maintains policies, SOPs, and compliance programs that strengthen internal controls and reduce regulatory risk in 503A and 503B environments. Directs comprehensive audit and inspection programs, proactively identifying gaps, investigating discrepancies or potential diversion, and driving corrective and preventive action plans. Oversees controlled substance inventory management, including perpetual and physical inventories, reconciliation procedures, and resolution of variances in collaboration with pharmacy, operations, and quality functions. Manages the Suspicious Order Monitoring program to identify unusual or high-risk ordering patterns, escalating concerns and ensuring alignment with DEA requirements. Provides leadership and guidance to compliance staff, coaching team members, promoting accountability, and embedding a culture of integrity and excellence. Serves as a secondary point of contact with DEA, FDA, state boards, providers, and internal stakeholders, supporting inspections, inquiries, compliance reviews, and issue resolution with professionalism and credibility. Compiles and delivers accurate reporting and data submissions to federal and state agencies, ensuring timeliness and completeness in all regulatory interactions. 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. The employee is 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
Strong working knowledge of DEA regulations, CFR Title 21, and state pharmacy laws. Hands-on experience with controlled substance inventory management, order fulfillment, audits, and discrepancy resolution, ideally in a 503A or 503B compounding pharmacy, pharmaceutical manufacturing, or healthcare compliance setting. Proven ability to support DEA audits, inspections, and regulatory interactions with professionalism, accuracy, and demonstrated success mentoring and leading compliance or regulatory teams with a focus on performance and development. 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
Minimum of 5 years of experience in pharmacy, healthcare compliance, or regulatory affairs, with at least 3 years in a leadership role. Bachelor's degree in Pharmacy, Regulatory Affairs, Compliance, or related field; advanced degree strongly preferred. Licensed Pharmacist or advanced degree in a regulatory or scientific discipline is strongly preferred. Preferred Certifications include Certified Healthcare Compliance (CHC); advanced pharmacy or regulatory licensure; DEA-related compliance credentials.
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/
Houston, TX
Posted:
September 23, 2025
Job Type:
Full Time
Req#
2025-5158
Legal
Position Summary
The Senior Manager, Controlled Substance Compliance at Empower Pharmacy is entrusted with ensuring the highest standards of regulatory alignment and integrity in the handling of controlled substances. Reporting to the Director, Controlled Substance Compliance, this leader plays a critical role in protecting patient safety and advancing Empower's mission to expand access to safe, high-quality, and affordable medication. With Empower manufacturing more than 300 million doses annually as the nation's largest 503A compounding pharmacy and an FDA-registered 503B outsourcing facility, this position is central to maintaining trust with regulators, patients, and providers.
Duties and Responsibilities
Ensures strict adherence to DEA, FDA, and state board regulations governing the procurement, receiving, storage, dispensing, reconciliation, and disposal of controlled substances across Empower operations. Develops, implements, and maintains policies, SOPs, and compliance programs that strengthen internal controls and reduce regulatory risk in 503A and 503B environments. Directs comprehensive audit and inspection programs, proactively identifying gaps, investigating discrepancies or potential diversion, and driving corrective and preventive action plans. Oversees controlled substance inventory management, including perpetual and physical inventories, reconciliation procedures, and resolution of variances in collaboration with pharmacy, operations, and quality functions. Manages the Suspicious Order Monitoring program to identify unusual or high-risk ordering patterns, escalating concerns and ensuring alignment with DEA requirements. Provides leadership and guidance to compliance staff, coaching team members, promoting accountability, and embedding a culture of integrity and excellence. Serves as a secondary point of contact with DEA, FDA, state boards, providers, and internal stakeholders, supporting inspections, inquiries, compliance reviews, and issue resolution with professionalism and credibility. Compiles and delivers accurate reporting and data submissions to federal and state agencies, ensuring timeliness and completeness in all regulatory interactions. 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. The employee is 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
Strong working knowledge of DEA regulations, CFR Title 21, and state pharmacy laws. Hands-on experience with controlled substance inventory management, order fulfillment, audits, and discrepancy resolution, ideally in a 503A or 503B compounding pharmacy, pharmaceutical manufacturing, or healthcare compliance setting. Proven ability to support DEA audits, inspections, and regulatory interactions with professionalism, accuracy, and demonstrated success mentoring and leading compliance or regulatory teams with a focus on performance and development. 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
Minimum of 5 years of experience in pharmacy, healthcare compliance, or regulatory affairs, with at least 3 years in a leadership role. Bachelor's degree in Pharmacy, Regulatory Affairs, Compliance, or related field; advanced degree strongly preferred. Licensed Pharmacist or advanced degree in a regulatory or scientific discipline is strongly preferred. Preferred Certifications include Certified Healthcare Compliance (CHC); advanced pharmacy or regulatory licensure; DEA-related compliance credentials.
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/