Position summary : The Pharmacy Manager (Controls) leads the day-to-day Controls function and supports security, accuracy, regulatory compliance, and inventory integrity of controlled substances moving through our facility. This role blends pharmacy operations, controlled substance management, DEA regulatory compliance, regulatory auditing, diversion prevention, inventory controls, and oversight quality/compliance to keep this highly regulated function audit-ready.
The role is a step up from the current Controls Supervisor position and adds broader responsibility for diversion prevention, inventory integrity, labor planning, team development, and regulatory compliance support. The Pharmacy Manager (Controls) partners closely with Compliance, Quality, Operations, and the DEA registrant on controlled substance requirements, inspections, reporting, investigations, corrective actions, and continuous improvement.
Key responsibilities:
DEA regulatory compliance
- Run Controls operations in full compliance with the Controlled Substances Act and 21 CFR Parts [redacted], including reverse distributor requirements.
- Maintain accurate, timely controlled substance records and support required regulatory reporting, including DEA Form 222 and CSOS orders, Form 41 destruction records, ARCOS reporting inputs, and receiving/shipping logs.
- Keep security controls current: vault and cage access, key and badge control, camera coverage and two-person integrity where required.
- Lead the Controls side of DEA, state board, customer, and internal regulatory audits; partner with Compliance and Quality to address findings and document corrective and preventive actions (CAPA).
- Monitor regulatory changes and partner with Compliance and Quality to translate applicable requirements into updated SOPs, work instructions, and training.
Diversion prevention and monitoring
- Support and continuously improve the diversion prevention program through risk assessments, surveillance review, access audits, exception monitoring, and operational controls.
- Detect and investigate discrepancies, losses, and suspicious activity; coordinate with Compliance and the DEA registrant to support timely DEA Form 106 theft or loss reporting when required.
- Partner with HR, Security and Compliance on investigations, background checks and employee screening for controlled substance access.
Inventory control
- Oversee inventory accuracy for all controlled substances from receipt through final disposition.
- Run cycle counts, the biennial inventory and reconciliations; resolve variances to root cause.
- Maintain chain of custody and segregation for Schedule II-V product, recalls and quarantined items.
- Use WMS and inventory data to spot trends, prevent errors and report KPIs to leadership.
Labor planning and operations
- Forecast volume and build staffing plans, schedules and cross-training to drive operational excellence.
- Set and manage productivity and quality standards; balance workload across shifts and peaks.
- Lead continuous improvement using Lean, 5S and standard work to cut errors, rework and cycle time.
Training and development
- Maintain onboarding, DEA compliance, controlled substance, and SOP training; keep training records audit-ready.
- Coach, develop and evaluate direct reports with clear goals, regular one-on-ones and documented feedback.
- Build a bench of trained backups and future leads for every critical Controls task.
- Foster a culture where accuracy, speaking up and doing it right the first time are the norm.
Accuracy and attention to detail
- Set the standard for zero-defect documentation and hold the team to it through audits and spot checks.
- Review and sign off on critical records, reconciliations and destruction documentation.
- Treat every discrepancy as a signal: investigate, fix the cause and verify the fix.
Qualifications Required:
- Bachelor's degree in supply chain, operations, business, life sciences or a related field, or equivalent experience.
- 5+ years in pharmaceutical distribution, reverse distribution, pharmacy operations or another DEA-registered setting.
- 3+ years leading people, including hiring, scheduling, coaching and performance management.
- Working knowledge of DEA regulations for Schedule II-V substances, including Form 222/CSOS, Form 41, Form 106, ARCOS, recordkeeping, security requirements, and controlled substance compliance practices.
- Proven record of inventory accuracy and experience supporting regulatory, DEA, state board, customer, or internal audits.
- Strong skills in Excel and a warehouse management or inventory system.
- Able to pass a background check and drug screen, and to meet DEA employee screening standards for controlled substance access.
Preferred:
- PharmD or active pharmacist license (optional, not required).
- Certified Pharmacy Technician (CPhT), APICS/ASCM CPIM or CSCP, or a Lean / Six Sigma Green Belt.
- Experience with reverse distribution, returns processing or hazardous waste rules (RCRA, EPA Subpart P).
- Experience supporting DEA inspections, regulatory audits, CAPA activities, or continuous improvement of a diversion prevention program
