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Job #03026

About our client Our client is a rapidly growing company manufacturing custom and specialty chemicals serving the pharmaceutical and biotechnology industry. The company has an experienced management team, a strong track record with the FDA and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director of Quality Assurance East Coast, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish, implement and maintain formal processes and procedures for the company’s quality system 2) Work with individuals designated with the task and authority for various quality system processes and procedures to ensure effectiveness and compliance 3) Assist functional heads of departments and designers in establishing SOPs and work instructions 4) Administer and oversee Corrective and Preventative Action Program 5) Ensure compliance with activities in the company and at contract facilities related to FDA and EU-Notified Body inspections, governmental actions and follow-up activities 6) Plan and implement quality system processes and procedures for a compliant in-house manufacturing facility 7) Identify and lead programs to improve quality, productivity, cost and customer satisfaction 8) Hire, train and direct managers, supervisors and other quality personnel 9) Establish a quality program for effective controlling of major contractors and suppliers 10) Participate actively in the development of business and departmental plans to support corporate goals and objectives Requirements 1) Bachelor’s degree in scientific field/other advanced degree in Science 2) 8+ years of work experience in quality control, quality assurance or regulatory affairs 3) Experience in both large pharmaceutical and start-up companies a plus 4) Previous experience in managing overseas staff in India 5) Knowledge of global regulatory approval and compliance processes 6) Excellent project-management skills 7) Strong problem-solving and communication skills 8) Willingness to travel internationally – up to 30%