Position Summary

　　The Director of Quality is responsible for the development, alignment and implementation of the Quality Management Systems, Regulatory and Complaint Management strategies. This position also provides insight, solutions and direction on general business matters as it is related to the Quality Department. This position is responsible for directing and leading the companys policies involving government compliance as well as national regulations.

　　Essential Functions:

　　Oversee the establishment, implementation and maintenance of the quality and regulatory management systems

　　Serve as the Designated Representative to government officials of states and other entities

　　Designs, develops and maintains quality systems

　　Responsible for Complaint Handling, Compliance, and FDA issues

　　Ensures that cGMP requirements and quality standards are recognized, understood and maintained across the Company

　　Prepares and leads the audit processes for the internal quality system, customer, DEA, OSHA and FDA

　　Identifies corrective actions and drive associates to accomplish correction action efforts

　　Monitors changes to quality regulations and guidelines, advising the management team of any business implications of these changes.

　　Makes recommendations for corrective and preventive actions necessary to ensure conformity with regulatory rules and guidelines

　　Ability and willingness to use accurate judgment, and make timely decisions

　　Ability to identify and resolve problems in a timely manner and gather and analyze information skillfully

　　Observe and apply organizational policies, laws, rules and regulations

　　Qualifications:

　　Masters Degree preferred; Bachelors Degree required in Technical or Medical field, or a closely related field

　　5 to 10 years of experience in Quality Management

　　Strong Knowledge of cGMP Requirements

　　Experience in pharmaceutical industry, preferably oral solid dose packaging

　　Knowledge of current regulatory requirements and industry standards particularly in the areas of manufacturing and packaging, label control, document management and investigations

　　Knowledge or experience in Complaint Handling

　　Strong knowledge and experience in a highly regulated or FDA environment

　　Strong supervisory and leadership skills

　　Proficiency with Microsoft Office programs such as Word, Excel and PowerPoint

　　Well-organized and detailed oriented professional with strong verbal and written communication skills