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Job #03650

About our client Our client is a well-known leader in the pharmaceutical contract manufacturing sector, offering outsourced services through the full product life cycle. They have over 100 years of success and have been on a steep growth curve over the past decade. This is a unique opportunity for a compliance professional that wants to put their drive and initiative to work for a highly reputable company with a bright future. Position Location Compliance Manager New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage oversight of domestic and international audits/inspections independently 2) Ensure compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols and industry standards and marketing authorization 3) Apply developed skills to ensure the facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports and/or controls are in conformance with applicable regulations 4) Ensure the monitoring and management of clinical studies are conducted in accordance with applicable regulations 5) Apply skills to ensure adherence to and application of GMP, GLP, GCP and CRP practices 6) Develop and deliver formal compliance training through various methods including formal presentations, on-line training, workshops and written materials 7) Maintain strict ethical, legal adherence and confidentiality at all times 8) Support the development and approval of quality service agreements and ensure adherence during site audits 9) Provide recommendations for corrective actions and track corrective action commitments derived from audit observations 10) Integrate compliance controls into the scope of existing business practices company-wide 11) Maintain professional expertise and knowledge of local and international regulations 12) Oversee and manage validation activities 13) Review and approve validation development reports and final summary reports 14) Serve as an active member of the Change Management Board to ensure the changes to critical systems are evaluated for validation requirements 15) Provide technical expertise in all aspects of validation principles Requirements 1) Ph.D./MS in a scientific or health-related field 2) Minimum 8 – 10 years of industry experience and 4 – 6 years auditing experience in pharmaceutical industry 3) Experience in running internal audits of drug manufacturing facilities and leading external audits of facilities by FDA 4) Excellent interpersonal, communication and organizational skills 5) Strong project and staff management skills 6) Ability to work independently and maintain confidentiality of audit processes and internal investigations 7) Attention to detail 9) Willingness to travel domestic and internationally (up to 25%)