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Job #03246

About our client Our client, a world-leading CRO, provides a broad range of services to the pharmaceutical, biotech and healthcare industries for the development and commercialization of various therapeutics. Position Location Quality Assurance Manager Research Triangle, North Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide support to the management in promoting and assessing compliance with GCP regulations/guidelines/operating procedures 2) Manage the QA supervision programs for the assigned projects and operational areas 3) Act as a Line Manager for 3 – 5 QA professionals 4) Prepare and distribute reports of findings to Operations Staff, management and customers 5) Manage investigation of quality issues 6) Host customer audits and regulatory inspections 7) Provide consultation in interpreting regulations and guidelines as well as policies and procedures 8) Establish/maintain relationships with internal customers such as project unit heads, operational and regional heads as well as their management teams and external customer QA functions Requirements 1) Bachelor’s/Primary Degree 2) Minimum 7 years of QA experience in a pharmaceutical, technical or a related area including GCP quality assurance and auditing experience 3) 5 years of management experience 4) Excellent knowledge of current GCP regulations/guidelines and associated regulatory requirements 5) Knowledge of pharmaceutical research and development processes 6) In-depth knowledge of quality assurance processes/procedures 7) Superb interpersonal, problem-solving, risk analysis and negotiation skills 8) Excellent leadership, organizational, team-orientation and communication (written and oral) skills 9) Ability to take initiatives 10) Ability to work in a team as well as independently