Director, Controlled Substances Compliance

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

The Director of Controlled Substances Compliance reports to the Vice President, Head Litigation and Corporate Counsel, and leads Par Health’s (the “Company’s”) Drug Enforcement Administration (DEA) compliance function, which is a critical part of the continued success of the business. This position is also at the center of the Company’s industry-leading Anti-Diversion Program, which focuses on addressing the issues of diversion and abuse of controlled substances products. The position requires in-depth knowledge of DEA regulations and the ability to interact in a professional manner with Company leadership, personnel from the DEA Field Offices and DEA Headquarters, and representatives from large wholesale and retail chain customers.
The Director of Controlled Substances Compliance is responsible for synchronizing controlled substances reporting, quota requests, quota tracking, DEA audit preparedness across sites (St. Louis, MO; Fenton, MO; Hobart, NY; Webster Groves, MO; and Rochester, MI) as well as interacting with various functions across the business including Commercial, Supply Chain, Customer Service, Manufacturing, Quality, and Trade Compliance.
As a subject matter expert on DEA regulations, this position is ultimately accountable for the Company’s systems and procedures to maintain the required closed system of narcotics distribution including: DEA and State registration license renewals, quota consumption monitoring, quota request submissions, DEA ARCOS reporting and State-mandated reporting, comprehensive recordkeeping, complete and accurate year end physical inventory counts, inventory reconciliation, discrepancy investigations, DEA narcotic raw material reports and DEA Close of Business Reports.
This position has primary leadership responsibilities for all DEA and State agency controlled substances-related inspections. Additionally, the Director of Controlled Substances Compliance is the primary contact for DEA Washington, DC when escalation is required for issues relating to quota, import/export permits and certificates of registration.
The Director of Controlled Substances Compliance participates in customer visits and delivers presentations covering the Company’s Quota and Anti-Diversion Programs.

Job Description

ESSENTIAL FUNCTIONS:

• Member of Suspicious Order Monitoring Leadership Team including evaluation of annual algorithms designed to detect customer orders of unusual pattern, size or frequency.
• Extensive work reviewing chargeback restrictions and reinstatements.
• Accountable for the preparation and submission of annual DEA federal license renewals.
• Oversees each facility’s input for monthly planning cycle and attends Sales, Inventory, Operations and Planning meetings on a monthly basis.
• Accountable for developing and maintaining systems for all required DEA records per record retention policy.
• Serve as the primary oversight representative for the Company on all controlled substances-related visits and audits by DEA, State Boards of Pharmacy, and other regulatory entities.
• Accountable for assuring a complete and accurate DEA year-end inventory.
• Interfaces regularly with external customers and vendors on controlled substances compliance matters.
• Provides oversight for review of discrepancy investigations from the controlled substances compliance perspective, which involves tracking through external parties (carriers, distributors, and 3PLs) and internally with Customer Service and distribution centers.
• Develop, maintain, and continually improve internal audit program for controlled substances compliance.
• Design and maintain an ongoing and updated education program for internal employees on controlled substances compliance as pertains to quota and anti-diversion programs.
• Provides controlled substances compliance expertise through active participation on cross-functional process improvement, product development, acquisition, external manufacturing and other teams.
• Management responsibility for timely destruction of controlled substances in collaboration with internal clients (EH&S, Manufacturing, Laboratories), witness burn facilities and reverse distributor vendors.  Assure that destruction transactions are entered in a timely manner.
• Investigate on an ongoing basis new controlled substances compliance concepts through continued education, seminars, training, and opportunities to participate in regulation and policymaking.
• Special projects as required, including supporting Legal requests.
• Drive follow-up activities related to DEA inspections and discrepancy investigations.
• Extensive interaction with Commercial and Supply Chain on quota matters and Customer Service on customer diligence and ordering, including initiation of improvement projects to enhance controlled substances order management processes related to controlled substances, CSOS and DEA Form 222 transactions.
• Collaborate with Commercial and provide external support such as meetings with customers and professional organizations.
• Evaluate alternative supply chain arrangements such as 3PL providers and distribution network for specialized products.
• Subject matter expert on complex quota matters.
• Panel member at industry conference on topics of quota and ARCOS.
• Other duties as assigned by the Vice President, Head Litigation and Corporate Counsel

MINIMUM REQUIREMENTS:

Education:

Bachelor’s degree preferred or equivalent relevant experience

Experience:

• 10 years of experience with the DEA required
• Experience in a pharmaceutical environment or other industry regulated by a federal agency preferred
• Previous supervisory/managerial experience required

Skills/Qualifications:

• Self-motivated - able to work with various departments internally and contacts outside of the organization
• Understanding of the rulemaking process and interpretation of regulations
• Must take initiative and act without direction when appropriate and ability to “act on his/her feet”
• Knowledge of regulatory reporting systems
• Excellent oral and written communication skills
• Detail-oriented
• Previous experience with DEA recordkeeping and DEA ARCOS reporting
• Working knowledge of Microsoft Office: Excel (including pivot tables), PowerPoint, Word
• Familiarity with data analytics and statistical process control

RELATIONSHIPS WITH OTHERS:

• The Director, Controlled Substances Compliance interacts with many functions across the business, including leadership, as well as externally with attorneys, consultants, customers, the DEA and State Boards of Pharmacy.
• The successful candidate must possess emotional intelligence in order to operate successfully in this role, balancing between DEA requests and internal stakeholders.

WORKING CONDITIONS:

Office based location in Hazelwood, MO with occasional travel to Company facilities in Missouri, New York, and Michigan, as well as to Washington, DC and customer sites throughout the US.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.