The Director, Quality & Regulatory Compliance is responsible for establishing a corporate Quality Assurance and Regulatory Compliance System and developing a team that promotes client satisfaction and positively impacts the financial performance of R&S Solutions and DCS, LLC. The Director will champion continuous improvement efforts and implement corrective action initiatives to establish an effective Quality Management System (QMS) including initiating and implementing quality improvement activities as appropriate (e.g., Kaizen, Six Sigma). He/she will educate and train the quality team and all company associates on the QMS and its relevance to their various roles.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

1. Develop, implement, manage, and integrate a QMS for R&S Solutions and DCS
2. Manage quality department including quality and compliance teams, establishing strategy and objectives for short-term and long-term planning and execution.
3. Design, implement and document procedures for process control, process improvement, testing and inspection in compliance with state and federal regulations including but not limited to FDA, cGMP, PDMA, DEA
4. Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound quality decisions
5. Perform root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
6. Establish collection and analysis systems of statistical data to predict trends that will affect improvement of service quality.
7. Analyze client specifications to establish efficient, cost-effective requirements for ease of delivery of all customer service requirements
8. Develop quality planning methods for all services to include R&S Solutions and DCS
9. Monitor vendor performance and establish criteria and scorecard for critical vendors and business partners.
10. Review client contracts, Quality Service Agreements and change requests and ensure that the necessary criteria and provisions are included in quality and process plans.
11. Support sales activities and review potential clients and existing clients for quality and compliance capabilities, or lack thereof.
12. Monitor and review all SOP’s annually and more frequently as needed for relevance and accuracy.
13. Interact with clients to identify opportunities to improve quality and establish open dialogue and feedback
14. Oversee calibration and testing programs, including temperature and humidity control.
15. Perform and monitor all required audits; both internal and external (DEA, FDA, cGMP, VAWD etc.). Act as Company representative when dealing with regulatory agencies and clients regarding quality and compliance issues.
16. Report to management on quality issues, trends, and losses.
17. Partner with Operations to understand shipping and receiving processes and procedures; provide feedback on process improvements and ensure quality and compliance standards are met.
18. Develop and train internal audit team to ensure processes are followed and non-conformances are addressed
19. Participate in senior leadership meetings assisting in setting overall goals and objectives for the organization

Competencies

1. Pharmaceutical Compliance and Regulatory
2. Technical Capacity; Automated Distribution experience.
3. Time Management.
4. Organizational Skills.
5. Communication Proficiency.
6. Strategic Thinking.
7. Financial Management.
8. Leadership.

Supervisory Responsibility

This position manages all employees of the Quality 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 as well as warehouse environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines; warehouse equipment such as forklifts, swing-reach and pallet jacks are utilized in this role as well.

Physical Demands

This is a combination of desk work and hands-on application within the warehouse. Actively monitoring activities on the warehouse floor.

Position Type/Expected Hours of Work

This is a full-time position, and hours of work and days are generally Monday through Friday, during 2nd shift hours.

Travel

Travel is required to multiple locations as business needs demand up to 30% may be expected.

Required Education and Experience

1. BS/BA in Quality Assurance; Manufacturing Engineering or other related discipline or equivalent combination of education and experience, specifically pharmaceutical distribution.
2. 10+ years in Pharmaceutical Industry.
3. 10+ years' experience in QA systems implementation and management with 5 years as a CQM in a pharmaceutical manufacturing environment preferred.
4. ASQ certification, RAPS certification is a plus.

Other Experience & Education Requirements

1. Broad knowledge of theory and principles of statistics and statistical process control.
2. Experience in designing and implementing quality systems.
3. Diverse knowledge of inspection and control methods, techniques and documentation.
4. Excellent communication skills (written and verbal).
5. Strong computer skills including quality control applications, word processing, spreadsheets, and databases.
6. 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.

R&S Solutions, LLC/ DCS, LLC is an equal opportunity employer. We provide equal employment opportunities to all qualified persons without regard to race, creed, color, religious belief, gender, sexual orientation, age, national origin, disability, veteran status, or any other status protected by law.