南京招聘

PURPOSE
Provide support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage the quality assurance oversight of projects, assignments, training and staff. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Manage the investigations of quality issues, customer audits and regulatory inspections. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Establish and maintain relationships with internal customers such as Project Unit, Operational and Regional Heads and their management teams and external customer Quality Assurance (QA) functions. Act as line manager for one or more QA staff.
RESPONSIBILITIES
？ Plan, conduct, and report audits of processes, systems, projects and/or sites within budget and established timelines.
？ Oversee and host the conduct of QA inspections and audits by clients and regulatory agencies and Mock FDA Inspections.
？ Prepare, review and approve corrective action plans.
？ Promote the concept of quality, the principles of quality management and devise and implement quality improvements.
？ Ensure implementation of Corporate Policies.
？ Represent QA on project related activities.
？ Act as a resource on all aspects of GXP and related guidelines and regulations.
？ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
？ Oversee and participate in the documentation, reporting, and closure of compliance issues.
？ Organize and deliver training to other Quintiles departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.
？ Serve as Regional or Global QA Liaison for assigned customers, therapeutic groups and/or functional areas.
？ Use the data available from Quality Assurance database (EDA) to provide information, metrics and trend analysis to assigned project, operational and regional units on the quality of procedures, practices, projects and systems.
？ Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
？ Maintain an excellent knowledge of current GXP regulations, guidelines, and related auditing techniques appropriate to work responsibilities.
？ Provide regular feedback to Quality Management, on the above activities.
？ Represent Quintiles at industry meetings, conferences, and seminars with presentations and training.
？ Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
？ Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
？ Serve as author of Quality Assurance SOPs as assigned.
？ Advise Quality Assurance management on system audit needs
JOB DESCRIPTION
？ Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
？ Act as line manager for one or more QA staff.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
？ An excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirement.
？ Knowledge of word-processing, spreadsheet, and database applications.
？ Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
？ Considerable knowledge of quality assurance processes and procedures.
？ Strong interpersonal skills.
？ Excellent problem solving, risk analysis and negotiation skills.
？ Effective organization, communication, team orientation, and leadership skills.
？ Ability to work independently with initiative.
？ Ability to manage multiple projects.
？ Ability to manage staff
？ Strong training capabilities.
？ Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
？ Bachelor’s/primary degree
？ 7 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 5 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
？ Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
？ Extensive use of keyboard requiring repetitive motion of fingers.
？ Regular sitting for extended periods of time.
？ Travel as required

    昆拓信诚医药研发（北京）有限公司是艾昆纬公司投资全资子公司，为美资CRO公司，依托艾昆纬公司全球高标准的质量管理系统和资源，昆拓形成了涵盖所有运营部门的完备标准操作流程（SOP）系统以及质量控制体系。
    昆拓秉承诚信、责任、合作、创新的公司文化，致力于成为中国本土临床研究服务的领跑者，以艾昆纬为依托，用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围，制定了严格的人才培养机制，为员工提供了良好的培训以及职业发展平台。
    人员一经录用，公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外，公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。