Empower Pharmacy
Senior Manager, Controlled Substance Compliance
Empower Pharmacy, Houston, Texas, United States, 77246
Senior Manager, Controlled Substance Compliance
Location:
Houston, Texas 77064, United States
Posted:
September 23, 2025
Job Type:
FULL TIME
Req#
5158
Company Overview Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We are the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving the functional medicine markets. We focus on People, Quality, Service, and Innovation, with a culture that empowers team members to share ideas and grow.
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 protects patient safety and advances 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 role maintains trust with regulators, patients, and providers.
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, identifies gaps, investigates discrepancies or potential diversion, and drives corrective and preventive action plans.
Oversees controlled substance inventory management, including perpetual and physical inventories, reconciliation procedures, and resolution of variances with pharmacy, operations, and quality functions.
Manages the Suspicious Order Monitoring program to identify unusual or high-risk ordering patterns, escalating concerns per DEA requirements.
Provides leadership 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 regulatory interactions.
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 setting.
Proven ability to support DEA audits, inspections, and regulatory interactions with professionalism and accuracy; demonstrated success mentoring and leading compliance or regulatory teams.
Key Competencies
Customer Focus
Optimizes Work Processes
Collaborates
Resourcefulness
Manages Complexity
Ensures Accountability
Situational Adaptability
Communicates Effectively
Values
People
Quality
Service
Innovation
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 CHC; advanced pharmacy or regulatory licensure; DEA-related compliance credentials.
Employee Benefits We offer comprehensive benefits to support health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, and access to compounded medications.
Learn more: https://careers.empowerpharmacy.com/benefits/
#J-18808-Ljbffr
Houston, Texas 77064, United States
Posted:
September 23, 2025
Job Type:
FULL TIME
Req#
5158
Company Overview Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We are the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving the functional medicine markets. We focus on People, Quality, Service, and Innovation, with a culture that empowers team members to share ideas and grow.
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 protects patient safety and advances 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 role maintains trust with regulators, patients, and providers.
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, identifies gaps, investigates discrepancies or potential diversion, and drives corrective and preventive action plans.
Oversees controlled substance inventory management, including perpetual and physical inventories, reconciliation procedures, and resolution of variances with pharmacy, operations, and quality functions.
Manages the Suspicious Order Monitoring program to identify unusual or high-risk ordering patterns, escalating concerns per DEA requirements.
Provides leadership 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 regulatory interactions.
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 setting.
Proven ability to support DEA audits, inspections, and regulatory interactions with professionalism and accuracy; demonstrated success mentoring and leading compliance or regulatory teams.
Key Competencies
Customer Focus
Optimizes Work Processes
Collaborates
Resourcefulness
Manages Complexity
Ensures Accountability
Situational Adaptability
Communicates Effectively
Values
People
Quality
Service
Innovation
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 CHC; advanced pharmacy or regulatory licensure; DEA-related compliance credentials.
Employee Benefits We offer comprehensive benefits to support health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, and access to compounded medications.
Learn more: https://careers.empowerpharmacy.com/benefits/
#J-18808-Ljbffr