Manager - DEA Compliance

Thermo Fisher Scientific•Cincinnati, OH

9d•Onsite

About The Position

This role provides technical and people leadership to the site Drug Enforcement Administration (DEA) Compliance team. The Manager is responsible for hiring, performance reviews, goal setting, achieving and reporting key performance indicators (KPIs), coaching, training, and prioritizing work for the group. The position evaluates process, system, and documentation improvements and drives ownership and accountability across the site to support adherence to regulations. The Manager leads DEA Regulatory Compliance Specialists and site Controlled Substance Program Coordinators, manages DEA inspections and inquiries, improves policies and procedures, educates employees, customers, and suppliers, and works with other sites and the network on benchmarking and audits. The role also monitors regulatory changes, supports quotes and new projects with DEA regulatory insights, and helps ensure continued supply of DEA-regulated products through improved site-wide business processes.

Requirements

Bachelor of Science or Bachelor of Arts preferred; equivalent combinations of education, training, and relevant work experience will be considered.
Education or experience in Quality, Supply Chain, Operations, Engineering, or another relevant business-related field.
Ability to drive functional, technical, and operational excellence.
Ability to drive multiple projects or initiatives simultaneously.
Understanding of ERP's role in inventory management and reporting.
Ability to pull data and compile it to formulate relevant site improvement initiatives.
Effective interpersonal, analytical, problem-solving, and oral and written communication skills.
Familiarity with Good Manufacturing Practices.
Strong computer skills, including Word, Excel, and PowerPoint.
Effective leadership and cross-functional team management skills.
Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
Positive, can-do attitude.

Nice To Haves

Experience working in a regulated distribution, manufacturing, or pharmaceutical environment.
Experience hosting regulatory inspections.
Experience implementing automated data management systems and reporting mechanisms.
Experience with import/export documentation and processes.
Knowledge of enterprise business systems and business software such as SAP, eBR/MES, TrackWise, and DMS.
Demonstrated experience leading, developing, and motivating cross-functional teams to achieve business objectives and drive results.

Responsibilities

Lead assigned staff and site Controlled Substance Program Coordinators, including organizational change, staff development, team building, engagement, and support for individual and organizational goals.
Manage DEA inspections, investigations, and inquiries, and coordinate follow-up on identified actions.
Evaluate and improve policies and procedures to ensure regulatory compliance; develop contingency and risk mitigation plans as necessary.
Serve as a communications liaison between Business Group Controlled Substance Program sites.
Educate employees, customers, and suppliers on DEA regulations and internal policies and procedures.
Identify and lead initiatives to automate manual processes; serve as a change leader within the department and site.
Create a metric tracker and track and report KPIs monthly or as required.
Ensure continued supply of DEA-regulated products by evaluating and improving site-wide business processes.
Collaborate with network sites to benchmark best practices and partner with the network to execute internal audits.
Monitor the Federal Register for regulatory changes.
Provide DEA regulatory insights for quotes and new projects.
Manage hiring, performance reviews, goal setting, KPI achievement and reporting, coaching, training, and work prioritization for the team.