1. Manage the Quality System for design and manufacture of regulated and non-regulated products, ensuring that the system meets applicable FDA & ISO requirements
2. Provide leadership and direction regarding all quality control initiatives for the company.
3. Maintain and advance quality initiatives using project management methodologies.
4. Ensure all existing products and those in the development stage comply with regulatory requirements in countries where marketed.
5. Ensure proper documentation of methods, protocols and reports.
6. Controls of supplier quality, product release and internal supplier audits.
7. Work with Purchasing on new supplier development initiatives as required.
8. Provide input to management, production, and marketing staff to determine manufacturing feasibility, cost effectiveness, and customer demand for new and existing products.
9. Anticipate and adapt the quality system to different markets and intensified regulatory climate.
10. Select and develop personnel to ensure the efficient operation of the quality department.
11. Responsible for reporting on the performance of the quality system to management with executive responsibility for review, irrespective of all other duties.
12. Responsible for recruiting and performance management of direct reports; ensures they are poised to meet the company objectives and goals; provides development opportunities, coaching and mentorship as well as execution of individualized Training and Development Plans (TDPs).
13. Provides fiscal leadership and continuous quality improvement principles and processes to improve quality and minimize operational expenses.
14. Performs related duties as assigned. 

• Must be able to understand inspection techniques for mechanical components/assemblies, electronic and electrical testing, sample plans, statistical quality control, and inspection and test jigs.
• Ability to utilize complex measuring equipment and tools.
• Must be able to lead and document an investigation.
• Excellent communication skills, both written and verbal.  Clear, concise report writing skills are key to this position.
• Able to work in a team environment.
• Flexible, able to handle multiple tasks/projects.
• Product development experience would be an asset.
• Experience in preparation for and support of FDA, ISO or other quality system audits
• Good analytical, conceptual and problem solving skills to evaluate business problems and apply knowledge to identify appropriate solutions; ability to resolve employee issues effectively and efficiently
• Ability to communicate effectively both orally and in writing; excellent presentation and group facilitation skills
• Ability to participate and drive major organizational change and operational initiatives
• Strong organizational skills; attention to detail and ability to meet deadlines
• Effective interpersonal skills, including high energy level, maturity, and creativity. 
• Excellent leadership, relationship building and teambuilding skills
• Ability to lead and energize multidiscipline work teams to learn and apply new skills and techniques to respond to business needs
• Excellent organizational skills; ability to manage aggressive timelines and pay close attention to detail; analytical
• Excellent ability to train, develop and motivate
• Computer skills: Microsoft Office Suite (including PowerPoint, Office, Outlook, Visio, Excel, Project) SharePoint
• Ability to travel as needed 

• Bachelor of Science degree preferred in pharmacy or a technical discipline (i.e.: engineering, sciences, math, pharmacy).
• Must be manufacturing oriented with 6-10 years of quality management experience in a manufacturing environment.
• Previous supervisory or management experience is preferred.
• An equivalent combination of education and experience would be acceptable. 

1.  Sedentary physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.
2. Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus.
3. 50% or more time is spent looking directly at a computer.
4. Associate is frequently required to stand, walk (or otherwise be mobile).
5. Ability to deal with stressful situations as they arise.

1. Ensuring that quality system requirements are effectively established and effectively maintained in accordance with FDA regulations; and
2. Reporting on the performance of the quality system to management with executive responsibility for review.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.