Plant QA Manager - Pharmaceuticals - (US-NC-Rtp )

Compensation: $115K - $115K / Year
Minimum Education: Bachelors
Job Type: Full Time
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Description
Directs the operations of the Quality Department to ensure product quality and regulatory compliance. Manages department resources in a manner to support and achieve stated departmental site business objectives. Operate the site quality system evaluating, analyzing and reporting on product and process quality performance and GMP compliance: Essential Functions; 1. Provides overall direction and leadership of the Site Quality System. Participates by assuring GMP compliance for plant and laboratory operations and manufacturing records; assuring finished product quality; assuring proper use of raw materials; directing sampling and inspection of raw materials and finished products; providing timely testing of production rates; and by auditing the components to ensure that they operate in accordance with established procedures and regulatory requirements. 2. directs site GMP training program to ensure regulatory compliance and promote continuous improvement; 3. Prepares and reviews department budgets and leads cost and efficiency improvement efforts within Quality as well as across the site in general; 4. Directs and facilitates investigation and resolution of accidents, incidents, process deviations and customers complaints and inquiries; Oversees all regulatory contact and coordinates plant response to regulatory inquiries; 6. Directs the development and growth of subordinat personnel, both direct and indirect; 7 Participates on the site staff team to provide overall leadership for the plant 8. Other duties as assigned

Requirements
BS Chemistry, Engineering, Life Sciences or related /MS preferred

5-8 years leadership experience in a chemical or pharmaceutical manufacturing environment, preferably specific to quality and/or manufacturing related functions.

Working knowledge of chemical, pharmaceutical or bio-pharmaceutical manufacturing. Must have knowledge and understanding of applicable global regulations, GMP compendial requirements. Experience in dirving improvements in quality systems and quality performance is preferred. Must have high technical ability and excellent inerpersonal/communication skills. Requires excellent oral and written skills and good negotiation skills to effectively communicate and influence the outcome of quality related plans, programs and activities throughout the business unit. Must have the ability and experience to drive cost reduction while continuously improving performance, as well as the ability to lead employees in making this changes. Skilled in the use of statistical techniques as applied to vendor, process and product quality control.

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