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Controlled Substances Program Manager

Fitchburg, WI 53711

Posted: 01/24/2023 Employment Type: Direct Hire/Perm Job Category: Quality and Compliance Job Number: 539645 Is job remote?: No Country: United States

Job Description

Job Description
The Chappelle Manufacturing Center (CMC) team consists of innovative professionals with diverse skillsets who work together to achieve our goal to safely manufacture high-quality small molecules that are used in our Life Science products to improve lives around the globe. 

YOUR ROLE: The Controlled Substance Program Manager is responsible for the implementation of our emerging Controlled Substance program to ensure compliant manufacture and distribution of clinically relevant psychedelic medicines. This role will provide subject matter guidance in the development of processes and procedures to uphold regulatory requirements and best practices. DEA regulated business activities include research, development, analysis, and API and drug product manufacturing at multiple registered locations.

CORE DUTIES: 1. Monitors the performance of the controlled substance program to understand and mitigate compliance risk. Communicates with cross-functional stakeholders and proposes improvements to the program.
2. Works in close partnership with site leadership, QA/RA, Logistics, Manufacturing, and lab staff, providing technical guidance and support with activities involving with controlled substances.
3. Writes and maintains procedures and forms related to controlled substances.
4. Develops and delivers training to employees.
5. Manages registration applications and renewals for all Federal DEA Registrations and State licensures.
6. Ensures security and access procedures and policies are adequate and maintained.
7. Coordinates and manages processes and documentation required for movement and transfers of controlled substances throughout manufacturing and operations.
8. Manages inventory reconciliation processes for all controlled substances at the registered sites. Responsible for investigating all inventory discrepancies of controlled substances. Leads investigations into the loss or theft of controlled substances.
9. Reviews manufacturing batch records and other cGMP documentation related to controlled substances as required.
10. Completes quarterly ARCOS, biennial, and year-end inventory reports for controlled substances as required by the DEA.
11. Develops and maintains all documents required for DEA quota applications, approvals, tracking, and amendments.
12. Executes, files, tracks, and audits DEA Form 222 order forms for both procurement and supply activities.
13. In coordination with logistics, completes DEA import and export permit applications via the DEA IMEX portal.
14. Conducts internal audits, following up on findings and corrective actions.
15. Leads external DEA inspections, interfacing with governmental agencies such as federal and state DEA representatives.
16. Coordinates the destruction activities for all controlled substances with lab staff, QA, EH&S, and Logistics and approves destruction methods in accordance with DEA requirements.
17. Maintains proper record keeping.
18. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
19. Embracing and being open to incorporating the 6 Emotional & Social Intelligence (ESI) core principles in daily work.
20. Understands and complies with ethical, legal and regulatory requirements applicable to our business. 
KEY QUALIFICATIONS: 1. High School diploma.
2. 5-8 years direct DEA compliance experience or pharmaceutical experience that includes working directly with controlled substances.
3. Keen awareness and technical knowledge of DEA regulations and how they are applied in a pharmaceutical manufacturing environment.
4. Ability to build relationships by communicating effectively and thoughtfully, using diplomacy and tact.
5. High degree of initiative with demonstrated ability to work independently and meet timelines. Ability to be calm when situations are stressful or ambiguous.
6. Able to adapt to changes in priorities based upon shifting business needs.
7. Ability to utilize tools and technologies to create seamless business interactions, connections, and transparency.
PREFERRED QUALIFICATIONS: 1. Familiar with working in a cGMP environment and compliance with FDA regulations.
2. Proficiency in inventory management and other controlled substance compliance systems (SAP, CSOS, etc.).
PHYSICAL DEMANDS: 1. Must be able to move around/about the facility in laboratories and manufacturing suites.
Target Salary Range: $93-$140k; salary will be commensurate with experience
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