To directly manage all Quality Assurance activities in support of External Operations for domestic CHC and Rx business units, and identify and mediate the risk to the company and monitor the compliance and execution of external manufacturing quality systems.
Major responsibilities include but are not limited to:
* Acts as primary contact/facilitator for external suppliers on all quality related issues.
* Contains and leads investigations related to operational deviations using a variety of analytical tools according to cGMP, insures external suppliers and sites are made aware of corrective and preventative actions, reviews and approves documents (i.e. deviations) , works with departments to develop, evaluate and implement action plans which maintain/improve product and process quality.
* Provides technical assistance on all quality related issues for products produced at an external supplier.
* Manages and communicates all change control activities related to equipment, facilities, process, materials, and systems of the external manufacturer to appropriate SME's.
Required Experience:
* Bachelor's degree in a scientific discipline or closely aligned field, with Master's degree preferred.
* Six to eight years professional experience in pharmaceutical Quality or Operations, and depth knowledge and experience in adjacent pharmaceutical categories such as API, Medical Device, Sterile, Dietary Supplements.
* Strong grasp of cGMP standards and requirements in an FDA regulated industry and the ability to interpret and apply these regulations and their application.
* Excellent oral and written communication skills at all levels of the organization and good interpersonal and relational skills.
