Manager, Drug Enforcement Administration
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About 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 Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who