DEA Quality Manager - NJDC

Job purpose

This position ensures that proper analytics are done for related DEA affairs and ensure due diligence on DEA controlled actions such as license request, quota, DEA permits, DEA reportable forms. As a complementary duty, this position supports the NJDC Quality team in resolution of investigations and non-conformances as well as their associated CAPAs. This position will ensure that Sun sites are aligned in terms of process and systems to ensure compliance to pharmaceutical GMP requirements. 

Duties and responsibilities

• Monitor the use of DEA 222 order forms and electronic forms (CSOS) for compliance with DEA requirements. Assist with the development and revision of procedures to ensure accurate documentation, traceability, and accountability as it relates to controlled dangerous substances (CDS) to minimize the risk of diversion
• Review cycle count audits of finished goods inventory, investigate inventory discrepancies and in-transit losses, and report findings to the DEA as necessary and ensure process improvements
• Oversee shipments associated with controlled substances and ensure their appropriate receipt process and storage by DHL operations
• Audit DHL operations associated with handling and storage of the controlled substances and oversee their improvement and gap closure activities
• Manage, prepare and submit periodic reports for the DEA including ARCOS Reporting and Year End Reports (YEARS)
• Oversee annual procurement quota and submit for additional quota if required
• Provide support with DEA audits both internally and externally to ensure that established procedures are being followed and documented, required reports are being filed, and inventories are reconciled
• Carry out duties in compliance with all local, state and federal regulations and guidelines including FDA, DEA, EMA, EPA and OSHA
• Successfully complete regulatory and job training requirements; remain current in skills and review industry trends
• Oversee and monitor the open nonconformance’s to ensure all activities are being completed in a timely manner as a site SME; complete an independent review of the nonconformance deviation reports and assess correctness of their root cause analysis and assign action items as necessary
• Ensure that regulatory guidelines and Standard Operating Procedure (SOP's) are being followed
• Update and review SOPs, Work Instructions, Forms and Templates as required; draft, edit and approve local department procedures in the Learning Management System
• Act as SME for Quality-focused systems/projects; provide training on Quality concepts or systems including annual GMP training when required

• Participate in process improvement activities including assessment of the current processes, providing improvement input and working with partners to implement changes
• Perform other duties as assigned

Education and Job Qualifications

• Minimum Bachelor’s degree or equivalent experience
• Minimum 6 years’ experience within DEA role in a pharmaceutical or related industry.
• Experience in dealing directly with Regulatory agencies officials such as DEA
• Experience in management of controlled substances program
• Excellent knowledge of DEA guidelines and regulations
• Capable of leading and influence in a matrix environment
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
• Experience in Quality electronic systems such as Trackwise, Learning Management System (LMS) and Electronic Management System (EDMS) is preferred.
• Ability to interact both interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
• Ability to work under stressful conditions and prioritize workload
• Able to problem solve complex problems that may arise.

Physical requirements

• Office based role
• While performing the duties of this job the employee frequently is required to sit, stand; talk, hear, walk, stoop kneel, crouch, crawl; use hands and fingers to operate a computer, telephone, keyboard and mouse.
• Lifting up to 50lbs. is required. 
• Travel Estimate: up to 5%

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).