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Job #03527

About our client Our Client is a global manufacturer and marketer of over-the counter and prescription generic pharmaceutical products with offices based in Israel, Canada and USA. Due to expansion, our Client is seeking a VP of Quality Compliance to head up their quality division in New York. This is an executive role that will develop, lead and execute the company's quality strategy. The candidate will lead the oversight and integrity of Quality Assurance, Quality Control and Compliance for our Client Position Location VP of Quality Compliance New York City, NY Salary Highly competitive package, commensurate with experience Responsibilities 1) Consult and train for all quality matters 2) Ensure compliance with International cGMPs and the GMPs of both the country of manufacture and the country of export 3) Work with senior management aids in determination of extraordinary matters (recalls, withdrawls, regulatory matters, compliance issues, etc.) 4) Ensure compliance of all goods with marketing application in both the country of manufacture and where it is being exported (ANDA, ANDS, etc.) 5) Participate as much as reasonably possible in quality, manufacturing and warehousing meetings of Technical Operations group 6) Ensure that all individuals have adequate training for their position 7) Conduct (or causes to be conducted) regular audits (scheduled and unscheduled) of the QA/QC department as well as manufacturing of all sites (or cause such audits to occur) and makes either on site recommendations and improvements or obtain a timetable and commitment 8) Ensure that appropriate actions are taken so that all vendors and contract manufacturers have adequate GMPs and are appropriately audited as well as supply appropriate documentation for this 9) Conduct or review audit reports of outside vendors (raw material and contract manufactures and testing sites including clinical testing sites) to confirm that our products or appropriate testing or studies are produced or performed under appropriate GMPs 10) Participate either in person, via video or by telephone in all regularly scheduled GMP compliance meetings 11) Is a consultant, advisor and trainer to senior management, operating personnel, R&D and QA/QC on all matters relating to quality compliance issues and regulatory matters relating to operational compliance 12) Thoroughly reviews all guidance’s (ICH, FDA, MOH, TPP, etc) relating to quality matters and reports on same to appropriate personnel 13) Keep abreast through reading, contacts and attendance at workshops the latest GMP, other compliance trends and enforcement priorities 14) Attend as a spokesperson for the parent, all regulatory inspections that are appropriate 15) Budget responsibility for the QA/QC group, including purchasing of new equipment 16) Facilitate introduction of new products to the facility/new business 17) Strive to improve the efficiency and timelines of the delivery of the Department’s services 18) Respond to customer inquiries and complaints 19) Review documentation with a view to release of components or product Requirements 1) BS in Science 2) 8 – 10 years of experience in a pharmaceutical operation, including at least 3 years in overseeing QA/QC compliance 3) Appropriate training and experience in FDA Law and regulations and cGMPs (including but not limited to validation, cleaning, process and computer) auditing of pharmaceutical operations and auditing of QA/QC laboratories and procedures 4) Ability to interact with all levels of personnel and to communicate effectively both orally and in writing 5) Complete knowledge of cGMP, FDA, TPP requirements, wet chemistry 6) Knowledge of pharmaceutical standards, validation; MRPII (BPCS preferred) Preferred: 7) 3 years direct industry experience in ore or all of QA/QC, manufacturing or consulting to industry 8) Exposure to international GMP compliance and international regulations 9) FDA headquarters experience 10) 5 years experience as an FDA inspector for pharmaceutical operations 11) Advanced degree in a science (MS or Ph.D.)