Director - Quality Assurance Location: Upstate New York State Industry: Pharmaceutical Chemistry Services Job Description: The Director is responsible for leading the quality assurance program, constantly bringing new developments in regulations and industry best practices to the Company's quality assurance program. This will include: Establish and maintain a risk-based and scientific-based quality system to protect the public health and to meet the Company’s business needs. Through a quality system approach, ensure all GMP operations are in compliance, while maintain an efficient workflow to facilitate the operational excellence. Establish and maintain an efficient and complaint validation program including process validation, cleaning validation, computer software validation, and instrument qualification. Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development as appropriate. By improving individual performance and group collaboration, the Director will be responsible for improving the overall department productivity and efficiency. Oversee, and be ultimately responsible for, the Company’s quality assurance program. This includes overseeing and assisting with the Company’s training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records. Along with the QA Associates, be responsible for the release or rejection of GMP materials. Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function Act as company’s representative during regulatory agencies and customer inspections. Identify and lead operational excellence initiatives, both in the department and company wide, which result in the overall improvement in both areas. Partner with colleagues in other departments to increase the overall effectiveness of the Quality department. Audit the manufacturing facilities of vendors, customers and outside contract organizations Position Requirements: Minimum B.S. degree in Chemistry or related field Leadership experiences – integrity, experience with operational excellence (Lean, 6Sigma, Lean6Sigma etc.), and organizational development (talents development, system development) A focus on strategy Superior influential and negotiation skills Solid knowledge in FDA regulations, especially the cGMP for the 21st century initiatives At least 5 years QA experiences in API and/or drug product (minimum 3 years in a management role); more experience is preferred