QA/Regulatory Client Services Manager

 On-Site QA/Regulatory   Client Services Manager

 

In conjunction with our client, Shuster Laboratories is very pleased to present an exciting job opportunity.  We are currently recruiting for someone who will be on-site at our client's location as a Shuster employee and who will act as the liaison between Shuster, our client and vendors. 

 

In this role you will work directly with our client's management team to support their overall quality standards and protect the store brand equity.  You will be responsible for developing systems and processes that ensure the highest level of store brand product quality in the drugstore industry.

 

Job Responsibilities:Monitor and improve overall quality for the store brand in order to reduce chance of recalls and customer dissatisfaction.Coordinate products withdrawals, recalls and regulatory filings/requirements for Store Brand or national brand (i.e. Class 1,2,3 and FDA recall audits, adverse events, etc.)Measure vendor compliance to quality standards (regular reporting/scorecard)Assist with EPA product registrations.Consult with management team on all business reviews with suppliers.  Give direction on product differences based on quality assessments.Develop systems and procedures to maintain data and track product/vendor performance; initiate and implement appropriate corrective action plans when deficiencies/deviations are found.Coordinate all aspects of the QA program between the analytical testing laboratory, the vendors and the client.Coordinate testing priorities and vendor cGMP audits.Support Category Managers with expert opinion on product quality and support regulatory compliance for domestic and imported products.Keep up to date with current FDA and ancillary regulatory bodies as related to regulations and guidance.Review label/labeling for regulatory compliance to FDA, FLPA, CTFA, etc.Develop action plans and recommendations for products that do not meet standardsTrack and trend customer complaints and returns and respond to alert or action limits accordingly.

 

Necessary Skills:BS in related field.  5-7 years experience with private label chain drugstore product categories. Knowledge of product and regulatory compliance for cosmetics, foods, dietary supplements, adjunct medical devices, OTCs and general merchandise.Extensive testing, quality assurance and regulatory background and the ability to understand and interpret laboratory data.Excellent communication and rapport building skills.  You will interface will all levels of management.The ability to come up with dynamic innovative solutions and ideas and skilled recommendations to unique situations. Creative problem solver.Ability to make presentations to Category Managers and Upper Management regarding the quality program.Ability to manage multiple projects at once.