Responsible for managing the overall quality and compliance system and team at Direct Customer Solutions. Champion continuous improvement efforts and corrective action initiatives to maintain an effective Quality Management System (QMS); initiate and implement quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company's service. Educate and train quality and compliance associates on their day-to-day job requirements. File and maintain required FDA, DEA and Foreign Trade Zone reporting.
Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Manage the FDA, DEA and Foreign Trade Zone regulatory requirements for Direct Customer Solutions
Manage the quality/compliance department including: quality assurance and compliance teams. This includes all licensing and reporting as well.
· Implement and document procedures for process control, process improvement, testing and inspection in compliance with federal regulations including but not limited to FDA, cGMP, PDMA, DEA.
· Implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions
· Perform root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
· Collection and analysis of statistical data to predict trends that will affect improvement of service quality.
· Perform quarterly audits around all processes in the operation.
· Oversee overall inventory management and
· Analyze customers' product specifications to establish efficient, cost-effective requirements for ease of delivery of all customer service requirements
· Review customer contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans.
· Interact with customers to identify opportunities to improve quality and establish feedback with service and development associates.
· Oversee calibration and testing programs.
· Report to management on quality issues, trends and losses. Participate in internal and external quality audits.
· Manage and develop quality team of up 15 people
Competencies
· Technical Capacity.
· Time Management.
· Organizational Skills.
· Communication Proficiency.
· Strategic Thinking.
· Financial Management.
Supervisory Responsibility This position manages all employees of the department and is responsible for the performance management and hiring of the employees within that department.
Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Physical Demands This is largely a sedentary role; however, some walking, lifting, bending and stooping may be required.
Position Type/Expected Hours of Work This is a full-time position, and hours of work and days are generally Monday through Friday, during day shift hours.
Travel Travel may be required to conferences or other company locations or client locations.
Required Education and Experience
· BS/BA in Logistics, Manufacturing Engineering or Business Administration
· 5-7 years' experience in QA systems implementation and management CQM preferred
- Pharmaceutical experience is preferred
Other Experience & Education Requirements
· ASQ certification is preferred, RAPS certification is a plus.
· Broad knowledge of theory and principles of statistics and statistical process control.
· Experience in managing implementing quality systems.
· Diverse knowledge of inspection and control methods, techniques and documentation.
· Excellent communication skills (written and verbal).
· Strong computer skills including quality control applications, word processing, spreadsheets and databases.
· Thorough understanding of general safety requirements.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Job Type: Full-time
Job Type: Full-time
Pay: $90,000.00 - $125,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Relocation assistance
- Vision insurance
Schedule:
Education:
Language:
Ability to Relocate:
- Bells, TN 38006: Relocate before starting work (Required)
Work Location: In person
