Manager – DEA Compliance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

Summary:

This role provides technical and people leadership to the site Drug Enforcement Administration (DEA) Compliance team and is responsible for all aspects of hiring, performance reviews, goal setting, achieving, and reporting Key Performance Indicators (KPIs), coaching, training, and prioritizing for the group. This individual is responsible for evaluating process, system, and documentation improvements and driving ownership and accountability across the site to ensure excellence in adherence to all regulations.

Essential Functions: 

1.      Provides leadership to assigned staff and site Controlled Substance Program Coordinators by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

2.      Manages DEA inspections, investigations, and inquiries; assures coordination and follow-up of identified actions.

3.      Evaluates and improves policies and procedures to ensure regulatory compliance. Develops contingency and risk mitigation plans as necessary.

4.      Serves as liaison for communications between Business Group CSP sites

5.      Educates employees, customers, and suppliers on DEA regulations and internal policies and procedures.

6.      Identifies and leads initiatives to automate manual processes. Serves as a change leader within the department and site.

7.      Creates metric tracker; tracks and reports KPI’s monthly or as required.

8.      Ensures continued supply for all DEA-regulated products through evaluation and improvement of site wide business processes.

9.      Collaborates with other network sites to benchmark best practices. Partners with the network to execute internal audits.

10.   Monitors the Federal Register for changes in the regulations.

11.   Provides DEA regulatory insights for quotes and new projects.

Supervision:

This individual leads a team of DEA Regulatory Compliance Specialists.

Education:

BS/BA preferred, with experience in Quality, Supply Chain, Operations, Engineering, or another relevant business-related field.

Preferred Experience:

1.      Experience working in a regulated distribution, manufacturing, or pharmaceutical environment.

2.      Experience hosting regulatory inspections.

3.      Implementation of automated data management systems, reporting mechanisms, etc.

4.      Import / export documentation and processes.

5.      Knowledge of enterprise business systems and business software

(SAP, eBR / MES, TrackWise, DMS, etc.)

6.      Demonstrated experience leading, developing, and motivating cross-functional teams to achieve business objectives and drive results.

Equivalency:

Equivalent combinations of education, training, and relevant work experience will be considered.

Competencies:

1.      Ability to drive functional, technical, and operational excellence.

2.      Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.

3.      Ability to drive multiple projects / initiatives simultaneously.

4.      Understanding of ERP’s role in the business with regards to inventory management and reporting.

5.      Ability to pull data and compile to formulate relevant improvement initiatives across the site.

6.      Positive, can-do attitude.

7.      Effective interpersonal, analytical / problem solving, and communication skills (both oral and written).

8.      Familiarity with Good Manufacturing Practices.

9.      Strong computer skills (Word, Excel, PowerPoint, etc.)

10.   Effective leadership / cross-functional team management skills.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.