​Director Quality Assurance

Position Summary

The Quality Assurance Director is the head of the Quality Department and reports to the Company’s Vice President of Quality Assurance & Regulatory Affairs. 

Essential Duties and Responsibilities include the following and other duties as assigned.

The Quality Assurance Director’s primary responsibilities are:

·       Managing the Quality Assurance Manager and Quality Department. 

·       Oversees all aspects of Quality and compliance with cGMPs. 

·       Oversees periodic internal audits of the Company for conformance to cGMP’s.

·       Oversees periodic audits and inspections of manufacturers for conformance to cGMP’s.

·       Submits and documents periodic product testing, including:

§  Testing for actives

§  Testing for banned substances

§  Oversees the Customer Complaint and AER systems

·       Communicates with manufacturers regarding quality issues and non-conformances.

·       Investigates quality issues and reports on findings.

·       Develops Standard Operating Procedures relative to the Quality Department.

·       Manages quality issues by overseeing Corrective and Preventative Action Plans in conjunction with the manufacturers.

·       Assisting Legal/Regulatory with market expansion documentation

·       Assisting Operations in qualification of potential manufacturers and suppliers

The Quality Assurance Manager’s additional responsibilities include the following:

·       Work with the Quality Review Board (QRB) on issues related to quality.

·       Other tasks deemed necessary by the QRB.

Education and/or Experience                  

·       Five plus years related experience and/or training, or equivalent combination of education and experience. 

·       Bachelor’s degree preferred.

·       Knowledge of Network marketing beneficial.

Qualifications/Skills

·       Proactive worker with very strong attention to detail and ability to self-check work on a daily basis.

·       Ability to prioritize workflow is essential.

·       Strong administrative and organizational skills – including ability to simultaneously manage multiple projects, with daily tracking and regular follow up.

·       Ability to mentor and lead junior level staff members.

·       Stellar oral and written communication skills are a must.

·       Exceptional organizational skills and attention to detail necessary.

·       Proficient in MS Office Products, including but not limited to, Word, Excel and PowerPoint.

·       Must be able to work in a dynamic, fast-paced environment and meet deadlines.

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