Controlled Substance Program Manager

1 month ago

Madison, United States Promega Full time

OUR TEAM:

The Promega 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 Promega's Life Science products to improve lives around the globe. To achieve this goal, we build strong relationships, collaborate openly, and embrace an attitude of "How can we do this the right way?" when we face challenges. We believe that to succeed as a team we need to create a space of optimistic learning and shared belonging, leveraging each other's strengths and celebrating our differences. We are looking to build our team with members who share these values and who are inspired to take on the new opportunities that inevitably await

YOUR ROLE:

As the Controlled Substances Program Manager at Promega, you play a crucial role in shaping the future of psychedelic research and manufacturing. This position offers the chance to apply your expertise in regulatory compliance and process optimization in a dynamic setting. You will be instrumental in supporting our mission to advance the field of medicine, collaborating with teams across research, development, planning, logistics, and manufacturing. Situated at the intersection of science and regulation, your contributions will directly contribute to the advancement of groundbreaking treatments, making a tangible impact across multiple DEA-registered locations.

CORE DUTIES:

1. Designs and executes processes in compliance with DEA regulations, navigating applicability across various registration activities to ensure business continuity.

2. Manages registration applications and renewals for all Federal DEA Registrations and State licensures.

3. Collaborates with leadership and various departments to integrate compliance into business processes, providing subject matter guidance to support emerging needs involving controlled substances.

4. Partners with the Security Department to ensure security and access devices, systems, and policies are adequate and maintained, balancing security needs with operational efficiency.

5. Maintains accountability for controlled substances through efficient, practical, and well-defined reconciliation and inventory management practices. Leads inventory discrepancy, loss or theft investigations.

6. Oversees controlled substance transfers, managing and coordinating related processes and documentation including DEA Form 222 order forms for both procurement and supply activities.

7. Monitors the performance of the controlled substance program and conducts risk assessments. Collaborates with cross-functional stakeholders to develop risk mitigation strategies, ensuring thorough consideration of all potential solutions.

8. Writes and maintains policies and procedures to meet regulatory and internal requirements, consulting with relevant functional areas.

9. Develops and delivers training to employees.

10. Leads process improvements to streamline operations while ensuring compliance, collaborating with stakeholders for effective implementation.

11. Completes accurate and timely quarterly ARCOS, biennial, and year-end inventory reports as required by the DEA.

12. Manages DEA quota application processes, gathering input from stakeholders to justify quantities required for manufacturing operations.

13. In coordination with logistics, completes DEA import and export permit applications via the DEA IMEX portal.

14. Leads external DEA inspections, interfacing with federal and state DEA representatives, informing leadership and providing updates to staff.

15. Conducts internal audits, following up on findings and corrective actions, fostering a culture of compliance integrated with operational excellence.

16. Coordinates destruction activities for all controlled substances and approves destruction methods in accordance with DEA requirements.

17. Maintains record keeping per DEA and state requirements.

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 Promega's 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. At least 5 years of direct experience with DEA compliance or in a role involved with controlled substance regulations.

2. Exceptional communication skills, with proven ability to build relationships across diverse groups, using diplomacy and tact.

3. High degree of initiative, capable of working independently and meeting deadlines. A willingness to be available after hours as needed to support operations.

4. Ability to manage multiple priorities concurrently, adapting to changing business needs while maintaining a sense of urgency for critical tasks. Maintains composure under stress.

5. Advanced critical thinking and decision-making skills, with experience integrating regulatory requirements and best practices into an organization's philosophy and operational strategies.

6. Strong attention to detail and commitment to high-quality work.

7. Proficient in using technology to improve efficiency and collaboration.

PREFERRED QUALIFICATIONS:

1. Keen understanding of DEA regulations and how they are applied in a pharmaceutical research and manufacturing environment.

2. Familiar with working in a cGMP environment and compliance with FDA regulations.

3. 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.

At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

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