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Job #03583

About our client Our client is a biopharmaceutical company focused on the development of new oncology drugs. Their growth has continued steadily over the past few years, and they are dedicated to each employee’s personal and professional growth. This is an excellent opportunity for the right person. Position Location Director, Quality Systems New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Serve as the lead for setting the strategic direction and overall management of the quality system for regulatory compliance 2) Oversee the direction of quality within the organization 3) Develop and implement all quality programs 4) Review and approve company quality records and develop strategic and tactical quality plans 5) Report on quality systems to executive management and serve as the process lead for the quality manual 6) Conduct quality system management reviews 7) Comply with all clinical trial materials (investigational drugs, IMPs) with the IND and/or IMPD in the country of manufacture and to where exported 8) Ensure that appropriate actions are taken so that all vendors, CROs and contract manufacturers have adequate GxPs and are appropriately audited 9) Supply appropriate documentation for this need 10) Consult and train for all quality matters 11) Ensure that all individuals have adequate training for their position and that appropriate training records are maintained 12) Review CRO and contractor generated deviations, write deviations, assign the final deviation category and approve as appropriate 13) Ensure effective operation of all aspects of the quality management syste 14) Assign CAPA actions and approve as appropriate 15) Review and approve change controls 16) Ensure that the SOPs reflect the current practices and are in agreement with the regulatory requirements 17) Develop and maintain GxP training plans as well as train and monitor the training for effectiveness 18) Help to develop the overall quality audit plan 19) Perform internal and external GxP audits either alone or as part of an audit team, depending on the nature of the audit 20) Prepare audit objectives/plans and audit reports and ensure timely follow up of all observations to a satisfactory conclusion 21) Conduct or review audit reports of outside vendors to confirm that products, appropriate testing, studies are produced or performed under appropriate GxPs 22) Review all guidance (ICH, FDA, MOH, TPP, etc) relating to quality matters and report on same to appropriate personnel 23) Keep abreast through reading, contacts and appropriate attendance at workshops the latest GxP, other compliance trends and enforcement priorities 24) Operate and maintain GxP document control system Requirements 1) MS or Ph. D. or an advanced degree in a relevant scientific discipline 2) 10 – 15 years of industry experience in a biologic, pharmaceutical and/or device manufacturing/development of which 3 – 5 years are in managing a quality/regulatory department in a biologics-based setting 3) Experience in operating a quality function and determining batch disposition (virtual and semi-virtual) 4) Exposure to international GxP compliance and international regulations 5) Experience in auditing and FDA inspections (and inspections by other relevant authorities) 6) Appropriate training and experience in FDA law and regulations and cGxPs 7) Quality management and/or regulatory certifications (CQM, CQA, CQE, RAC, etc.) 8) Ability to interact with all levels of personnel and to communicate effectively both orally and in writing