Manager, Drug Enforcement AdministrationPosition Summary:- This is a full-time salaried position, based out of our Kansas City, MO site
- Relocation assistance provided
The
Manager, Drug Enforcement Administration will oversee the state of DEA regulatory compliance of controlled substances at the Kansas City, MO site through the following: oversee the inventory and other aspects regarding the use and storage of controlled substances in pharmaceutical dosage forms in development, laboratory, manufacturing, and packaging environments. The
Manager, Drug Enforcement Administration will support all necessary regulations with DEA 21 CFR 1300 to end, Bureau of Narcotics and Dangerous Drugs and state licensure, state reporting and maintaining NABP Drug Distributor Accreditation.
Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction.
The Role:- Responsible to ensure order, receipt and process distributions are observed and recorded per site procedures to assure the inventory records of Controlled Substances are accurate and completed to meet DEA regulations
- Provide training for Authorized Associates approved to work with Controlled Substances and oversight of daily activities
- Assure new hires are appropriately screened and existing DEA Authorized Associates are rescreened, as required by site procedures while maintaining an accurate list of Authorized Associates at all times
- Support Audit Ready 365 initiatives including management of DEA inspections through ownership of DEA binder, tracking of observation findings and action completions in Trackwise, and other duties as required
- Provide support as DEA Subject Matter Expert, as required
- Responsible for the controlled substance programs at KCM to include holding Power of Attorney for DEA Registrations. Complete accurately, file, and submit (as required) DEA 222 forms, DEA imports and exports, completion of DEA renewal applications, File DEA 106s (theft and loss form), ARCOS, YERS, and required end of year reports
- Participate in all inventory variances, deviations, and/or investigations involving controlled substances
- Provide support of state licensure, including Drug Distributor Accreditation, through the review of applications; Ensure license expiration dates are monitored and renewal applications completed on time to assure KCM operates a GMP facility in compliance with Applicable Laws, including the requirements for state reporting of controlled substances
- Other duties as assigned
The Candidate:- Bachelor's Degree, required
- Minimum of five years of DEA Compliance experience, required
- Demonstrated people management over at least 3 direct reports, required
- Scientific and Quality Assurance experience, preferred
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
Why You Should Join Catalent:- Defined career path and annual performance review and feedback process
- 152 hours of PTO + 8 paid holidays
- Community engagement and green initiatives
- Generous 401K match
- Medical, dental and vision benefits effective day one of employment
