高级审计师, 供应商审计与合规
Senior Auditor, Supplier Audit & Compliance
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。我们致力于在免疫学、肿瘤学和神经科学等多个关键治疗领域对人们的生活产生重大影响，以及我们在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。关注我们在 LinkedIn、Facebook、Instagram、X 和 YouTube 上的账号。
高级审计师，审计与合规部门负责对符合美国及外国法规要求的全面审计，为艾伯维工厂、附属公司、质量服务区域和/或为艾伯维提供材料、服务和产品的供应商的质量相关系统提供建设性评估。负责支持艾伯维工厂执行供应商质量保证审计以及解决与供应商质量保证审计相关的CAPA计划。他们在GMP合规性和质量保证领域的执行确保活动按照艾伯维的政策/程序以及旨在保证产品质量、效果和安全性的适用质量和监管要求进行。该职位对艾伯维具有战术意义，必须在参与和客观性之间取得困难的平衡。
职责
- 根据适用法规评估系统的合规性、设施和流程，确保符合监管要求和艾伯维规范。
- 以审计观察结果的形式提供反馈，并审查纠正措施，以确定承诺是否已正确实施，证明有效，并在供应商或内部艾伯维场所持续保持。对于内部场所，制定纠正措施的建议。
- 参与战略举措，以提高对监管要求和标准的合规性。
- 在供应商审计方面，主要集中在流程更全面且对业务至关重要的关键供应商，并可能包括艾伯维工厂的审计参与。
- 与研发质量保证部门合作，协调并进行联合审计。
- 与内部利益相关者（如采购、SQA、EQA、制造场所和商业附属公司）以及外部利益相关者沟通和协调供应商审计活动。
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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.
Purpose:
Primarily responsible for carrying out comprehensive quality system audits of third-party service providers and manufacturers for compliance with applicable global regulatory requirements. Responsible for providing quality
consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide
Responsibilities:
· Carry out job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies.
· Independently plan and conduct external supplier audits assessing compliance of systems, facilities, and processes per applicable regulations and AbbVie specifications.
· Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained.
· Assist in maintaining approved supplier list, global audit schedule and participate in supplier management processes (e.g. Management Review, Supplier Change Notifications, etc.).
· Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners.
· Assist on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers.
· Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
· Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
· Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight.
· Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
· Collaborate with AbbVie Operations in coordinating and conduct of joint audits.
· Ensures audits are conducted according to the annual audit schedule.
This is an experienced level compliance position that reports to the Director RDQA External Partners Quality Audit or designee. This individual is expected to identify and resolve problems through effective interpersonal skills. The incumbent will work effectively independently or as a team, mentor others, and also be an effective cross-functional team leader. Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.
- Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
- Demonstrated strong leadership competencies, proficient level of technical capabilities, and
- independence. Proven track record utilizing core & technical competencies.
- 8+ years’ total experience, including 3+ years in compliance or auditing role.
- Sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries and thorough understanding of international GMP and Device regulatory standards (e.g. US FDA, EU, MDR/IVDR, etc.).
- Quality Assurance auditing experience (preferred)
- Pharmaceutical/Device Manufacturing experience (preferred)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)
- Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA))
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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