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Job #02821

About our client Our client is the API production division of a well-respected global pharmaceutical company. The company's growth has outpaced the industry for a number of years and they boast both an experienced management team and a commitment to maintaining a world-class corporate culture. This is a great situation for a candidate that is pursuing a challenging opportunity with the potential for career advancement. Position Location Director of Quality and Compliance Virginia, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and direct the development and implementation of quality policies, systems and procedures 2) Ensure that company complies with all regulatory guidelines 3) Develop and implement regulatory strategies, policies, procedures and optimal infrastructure to ensure site-wide compliance with all regulatory agencies (e.g., FDA, DEA and EMEA) 4) Ensure timely and accurate preparation as well as recording of all regulatory submissions and documentation, including batch records, DMFs, etc., for high-quality regulatory submissions 5) Oversee, lead, serve as host and liaise for all regulatory as well as customer audits 6) Provide direction and leadership in the area of customer complaints 7) Ensure that customer and regulatory authority requirements are met 8) Provide leadership in the area of controlled substance compliance 9) Design, implement and improve effective strategies (e.g. quota procurement and management) 10) Ensure company compliance in the manufacturing and reporting of all controlled substances 11) Provide overall direction, research and consultation with regard to all regulatory, compliance and quality matters (within the site) 12) Act as the company liaison for all quality and regulatory activities on both the internal and external level (i.e. within the company and with all regulatory bodies, like the FDA, DEA, EMEA, etc.) 13) Ensure that there is no company product supply disruption due to regulatory non-compliance or enforcement action 14) Guarantee that company’s quality processes are in agreement with corporate quality guidelines and procedures 15) Instill the values of the company quality process throughout the organization 16) Create and maintain a corporate culture, which emphasizes prevention, conformance to requirements as well as continuous improvement Requirements 1) Ph. D. in Chemistry, Chemical Engineering or a related discipline 2) Minimum 10 years of experience in managing or implementing quality systems and processes in any pharmaceutical industry (except medical devices) 3) Experience in managing a quality group of 25+ people 4) In-depth knowledge of cGMP, DEA regulations, FDA regulations and Q7A