Job Summary
The Director of the Corporate Controlled Substance Compliance (CSC) Department is responsible for leadership, oversight, and coordination of the Controlled Substance program including development and implementation of corporate policies, standards, procedures, and processes, while ensuring that continuous improvement techniques are utilized to improve the program. This role will partner with teams nationally within each distribution center, manufacturing site, and necessary corporate function (Legal, Customer Service, Financial Planning & Analysis, IT, Marketing, Master Data, Quality, Regulatory Labeling, Supply Chain, Commercial, Contract Marketing, Human Resources, EHS, and Medical Affairs and some teams globally) to ensure compliance with overall corporate program, regulatory requirements, and applicable standards and best practices.
This role provides oversight and subject matter guidance for controlled substance and List I chemical compliance needs in manufacturing, distribution, warehouse, logistics, Research & Development, clinical, QC and QA laboratory processes, import/export, drug disposal, reverse distribution, controlled substance security, suspicious orders monitoring and reporting, customer onboarding, drug theft/loss reporting, and ensuring overall effective controls and procedures are in place to protect against the threat of diversion. This guidance is done in close partnership with Quality and Operations Global team functions, as well as customers, regulatory bodies, and logistics contractors.
Oversight will cover review and harmonization of end-to-end importing, manufacturing, testing, destruction, drug waste disposal, distribution, packing, staging, license validation, transporting, loading, receiving, handling, processing, recordkeeping, documentation, reporting, inventory and reconciliation, overall accountability of controlled substance matters to enhance existing processes with cross-functional impact.
This role is the face of the program acting as a connecting point to the Chief Compliance Officer and ultimately accountable for all capabilities being in place across the organization. This leader will also partner with others in the organization to assess opportunities to shape the external environment with the DEA, FDA, Competent National Authorities, and industry groups to support adequate supply of controlled substance availability through quota requests and ongoing communication with DEA.
Responsibilities
- Promote a unified vision and holistic approach to controlled substance compliance throughout the U.S. by providing guidance, direction, and recommendations to all regional sites that handle controlled substances to ensure fulfillment with state and federal regulations.
- Support sites through a dotted line structure while maintaining a broader perspective on integrity and reputation among the corporate/global entity. This dotted line structure will encompass the Market Unit and the Global Business units.
- Supervise direct staff, consisting of Sr. Manager/Manager/Sr. Data Analyst daily as well as provide developmental opportunities and mentoring.
- Responsible for controlled substances program including providing oversight, sponsorship, and organizational decision making to include compliance investigations, and overlap with corporate security at the controlled substance handling locations.
- Ultimate ownership of all DEA reporting requirements including daily operations of SOMS (Suspicious Order Monitoring System) including oversight of each individual controlled substance order and the corresponding documentation that supports it.
- Develop, lead, and improve internal controlled substance policy and guidelines to meet or exceed regulatory standards, expectations, and requirements, including timely incorporation of regulatory changes.
- Sign off on major incidents, major internal/external audit reports, and follow up on significant findings. Inform executive leadership on major issues and provides updates.
- Responsible for development and execution of site DEA inspection readiness plans. Support sites with managing local DEA inspections, findings, and correspondences.
- Lead as the delegated National Narcotic Substance Responsible (NNSR) person as defined by gSOP "Handling of Narcotics" and support all controlled substance handling locations in the U.S. with adherence to global SOPs, and federal and state laws surrounding controlled substances.
- This role will lead, conduct, and document compliance investigations throughout the U.S., assess an appropriate course of action pursuant to regional and global case management policy, and collaborate/recommend appropriate outcomes with senior leadership or referral teams.
- Develop regional case management policy for U.S., in conjunction with Legal, HR, and Global Risk & Compliance Teams.
Job Requirements
- Bachelor's degree required with advanced degree preferred: MS, JD, or MBA.
- 10+ years of experience in a regulatory or compliance role in the biotech/pharma industry, including at least 5 years in a leadership role.
- Required Related Experience: Relevant experience in controlled substance environment in a pharmaceutical environment. Previous experience with global and/or USA DEA (or equivalent state agency) is preferred.
- Demonstrated understanding of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and other applicable regulatory requirements.
- Demonstrated knowledge as a subject matter expert including knowledge of the International Narcotics Control Board (INCB) and the National Drug Control Policy.
- Strong controlled substance industry network.
- Extensive knowledge of federal/state laws and industry requirements affecting the biotech/pharma industry.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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