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AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate QA Manager

Shanghai, Shanghai Municipality, China Req ID 2212641 Category Quality Assurance Division AbbVie
  • Responsible for the integration and support of quality regulations:  drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
  • Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance. 
  • Support activities related to product actions in the affiliate.
  • Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity. 
  • Responsible for partnering and overseeing support activities related to product actions in the affiliate. Oversee coordination and investigation of key quality systems (i.e. CAPA, product complaints) ensuring KPIs are being met. 
  • Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.  Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
  • Quality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.

  • Bachelor’s Degree in Chemistry, Pharmacy, Biology, other scientific area.
  • 3-4 years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred. Min 3 years’ experience in GSP related quality assurance
  • Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations. 
  • Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.
  • Strong influencing, motivational, interpersonal and relationship building skills at all levels. 
  • Excellent written and oral communication skills.  Proficiency in English. 
  • Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
  • Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache and Attache Pro.
Travel: No
Job Type: Experienced
Schedule: Full-time

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