审计师，研发质量保证临床质量审计 - 远程
Auditor, RDQA Clinical Quality Audit - Remote
关于艾伯维
艾伯维的使命是发现并提供创新药物和解决方案，解决当前严重的健康问题，并应对未来的医疗挑战。我们致力于在多个关键治疗领域，包括免疫学、肿瘤学和神经科学，对人们的生活产生重大影响，以及我们Allergan Aesthetics产品组合中的产品和服务。有关艾伯维的更多信息，请访问我们的网站 www.abbvie.com。在 LinkedIn、Facebook、Instagram、X 和 YouTube 上关注 @abbvie。
主要负责临床审计计划的执行，包括安排、规划、报告和临床审计的整改。尽可能确保与RDQA政策和程序保持一致，并参与临床QA质量体系的开发和实施。为业务合作伙伴提供关于GCP和质量主题的建议和支持，以确保符合全球要求和期望。
职责：
· 通过持续评估临床流程的审计和QA监督活动，在受监管环境中确保质量和合规性，包括全球法规、国家特定标准和其他适用标准以及艾伯维的政策和程序。
· 领导和参与临床审计的安排、规划和实施活动，以评估对法规、指南、艾伯维政策和程序及发起方要求的合规性。临床审计类型包括研究者临床现场、流程、系统和附属机构审计。
· 在目标时间范围内，以口头和书面形式有效沟通审计结果。
· 在目标时间范围内审查并批准针对审计观察结果提交的纠正措施计划，并跟踪措施至完成。
· 通过参与开发和实施支持全球质量保证要求的系统和流程，推动艾伯维质量体系的发展。支持维护或开发与临床审计相关的质量标准。
· 参与持续改进项目，以帮助确保符合法规和公司政策。
· 根据需要参与GCP检查。
· 为RDQA和业务合作伙伴提供有关GCP法规的支持和咨询。
· 促进自身和其他艾伯维员工对质量和临床指南及法规的持续教育。
- 科学学士学位（生物、化学、药学或相关专业）
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. Ensuring alignment with RDQA policies and procedures wherever possible and contributing to the development and implementation of the Clinical QA quality system. Provision of advice and support on GCP and quality topics to business partners to ensure compliance with worldwide requirements and expectations.
Responsibilities:
· Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.
· Lead and participate in Clinical Audit scheduling, planning and conduct activities to assess compliance with regulations, guidelines, AbbVie policies and procedures and sponsor requirements. Clinical audit types include investigator clinical site, process, system and Affiliate audits.
· Effectively communicate audit results, both orally and in writing, within target timeframes.
· Review and approve Corrective Action Plans submitted in response to audit observations within target timeframes and tracking of actions to completion.
· Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements. Supports maintenance or development of Quality standards relating to Clinical audit.
· Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies.
· Participate in and support GCP inspections, as required.
· Provide support and consultation to RDQA and business partners with regards to GCP regulations.
· Promote continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.
- Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
- 3-5 years of experience in the biopharmaceutical industry or with a regulatory authority
- 3-5 years of experience in Quality Assurance and/or Clinical Research Development
- Strong analytical skills and the ability to draw conclusions from presented data
- Ability to work effectively and efficiently in a dynamic environment with minimal supervision
- High level of awareness and understanding of clinical trial regulations (e.g. ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices
- Flexibility to adapt to changing assignments and ability to effectively prioritize
- Good project management, interpersonal, and communication skills with ability to work independently and as part of a team
- Willingness and ability to perform international travel
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
· The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
· We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
· This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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