To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02877

About our client Our client is a leading pharmaceutical company that has developed a reputation for successfully bringing complex products to the market in a variety of therapeutic areas. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Senior Quality Assurance Specialist North Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the operational implementation of project specific quality audit plans over clinical research and development activities, for multiple new drug development programs 2) Initiate, manage and follow-up on audits conducted by or on behalf of the company 3) Handle R&D, including planning, tracking along with supporting R&D studies and programs, to ensure that the audit program is executed in accordance with the overall R&D quality master audit schedule 4) Facilitate the development of auditing contracts, working with legal, finance and purchasing groups to develop requests for proposals 5) Review proposals and provide input regarding costs as well as scope of work 6) Coordinate activities of contract auditors to implement activities in accordance with the master audit schedule 7) Provide QA support to studies performed by Clinical Research, Pharmaceutical Development and Pre-clinical departments 8) Assess compliance with applicable FDA regulations (GCP, GMP and GLP), SOPs and protocols 9) Review audit reports from vendors for clarity, consistency and interpretation of results 10) Write or update quality manual(s), policies and SOPs, describing applicable audit practices and related compliance activities 11) Ensure that the comprehensive quality system meets regulatory requirements 12) Provide and implement effective solutions to quality issues and problems 13) Assist with the maintenance and management of the master audit schedule for providing budget forecasts to project management 14) Ensure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines 15) Provide support when questions of compliance or interpretation of regulations arise and recommend prospective or retrospective action plans 16) Ensure that all clinical projects have a written audit plan and also that auditors are assigned to complete the required audits 17) Contribute to process improvement initiatives across the organization 18) Identify FDA compliance issues/risks and propose strategy to manage/mitigate risks 19) Ensure timely execution of the audit plan 20) Assist in the management of quality complaints 21) Provide status reports for program meetings and senior management Requirements 1) BS, MS or Ph. D. in Life Sciences 2) Minimum 5 years of related pharmaceutical sponsor/industry experience in an FDA regulated, R&D environment in clinical QA (GCP preferred) 3) Experience in non-clinical laboratory or R&D GMP areas a plus 4) Minimum 3 years of direct GCP auditing experience, including clinical investigator sites, CROs, bioanalytical labs, IRBs, etc. 5) Knowledge of FDA, GCP and ICH guidelines/regulations 6) Expertise in GCP 7) Familiarity with GLP and cGMPs in an R&D environment 8) Excellent medical/scientific communication skills (written and verbal) 9) Proficiency in computer software (MS Project and MS Office) 10) Willingness to travel (10% – 20%)