Our Team, Your Impact
The position is responsible for strategic planning and management of remote site distribution activities while maintaining compliance with DEA Controlled Substance regulatory requirements, State Wholesale Distribution Compliance, PDMA guidelines, OSHA, Florida State 499 on Pedigree and EPA regulation. Serves as host for regulatory inspections, including but not limited to, DEA, VAWD, State Pharmacy Boards OSHA.
How You'll Spend Your Day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Oversees customer order fulfillment, ensuring consistent cycle times, order accuracy and customer carrier compliance.
• Coordinates new product launches and End of Quarter activities.
• Directs distribution center processes, facility design, layout, through-put and storage capacity.
• Responsible for implementing new technology and system enhancements. Defines requirements for system enhancements or efficiency opportunities, coordinates testing, training and ensuring SOPs and documentation are updated.
• Provide strategic and tactical guidance, leadership, support, and works in close collaboration with the business unit departments to develop and achieve distribution goals while maintaining regulatory compliance
• Keep records to ensure compliance with DEA regulatory requirements, DSCSA, PDMA, Florida Pedigree, State Pharmacy/Wholesaler regulations, OSHA, and EPA as well as all other regulatory bodies necessary.
• Acts as the Certified Designated Representative (CDR) single point of contact for ALL outside audits pertaining to the Distribution Center and Distribution Activities including record requests and subpoenas for record certification and testimony.
• Develops department goals and objectives.
• Coordinates project management activities across functional areas, as needed.
• Develops and modifies regulatory and compliance training and in-services, explain company policies to associates and enforce safety regulations. Develops and trains associates on DEA regulations pertaining to controlled substance handling of Schedule II-V products as required.
• Testifies on the Company's behalf when needed
• Develop quality programs and coordinate the creation and revision of all Distribution SOP's in relation to company, state, local, DEA, FDA and PDMA guidelines.
• Assures a synchronized flow of scheduled products; analyzes operations and improves productivity and efficiency as needed; writes reports and recommendations as needed.
• Assures all distribution operations are in compliance with Standard Operating Procedures (SOPs),), the Company's policies and procedures, and applicable federal and state laws and regulations.
• Ensures high level of inventory control and accuracy for all products.
• Monitors and approves the interviewing, hiring, and training of departmental employees; conducts performance evaluations for direct reports.
• Provides support, direction and coaching to subordinate employees in the areas of training, disciplinary action, problem resolution, planning, and work assignments.
• Performs related duties as assigned.
Your Skills and Experience
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
• Minimum of ten (10) years related experience; pharmaceutical industry preferred
• Bachelor's degree required; master's degree preferred.
Skills/Knowledge/Abilities:
• Food and Drug Administration (FDA), cGMP, SOPs, DEA and other pharmaceutical manufacturing and packaging regulatory requirements.
• Warehouse and distribution processes, equipment and safety requirements.
• Import/Export rules and regulations.
• Personal computer hardware and software applications.
• Management, leadership and training principles, practices and methods.
• Recruiting, interviewing and selecting applicants in accordance with established employment practices and methods.
• Current Company policies, practices and procedures, including safety regulations.
• Proficient in computer based design and implementation
• Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and techniques for resolution.
• Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
• Monitoring distribution operations and assuring compliance with all rules and regulations.
• Communicating clearly and concisely, both orally and in writing.
• Managing and prioritizing multiple projects, duties and assignments.
• Interpreting and applying Federal, state and local policies, procedures and regulations.
• Directing, supervising, coordinating and delegating assignments, and reviewing the work of assigned department personnel.
• Establishing and maintaining cooperative working relationships with others.
TRAVEL REQUIREMENTS
Approximately quarterly domestic travel throughout the US.
PHYSICAL REQUIREMENTS:
Occasional:
• Sitting for extended periods of time at work station or mobile equipment.
Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, and extensive reading.
WORKING ENVIRONMENT
• May be required to wear personal protective equipment (PPE) as needed on site visits (i.e. safety glasses, hearing protection, gloves, etc.).
Salary Range
The annual starting salary for this position is between $168,720 - $210,900 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.
How We'll Take Care of You
We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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