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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Quality Assurance
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1906875 Requisition #
Join our Talent Community

The Affiliate QC Manager is responsible for managing and providing supports to laboratory personnel in national QC lab.  Responsibilities include oversight of day to day operations in support of finished product local import testing requirements including handling of documentation, oversight of knowledge tranfer, training, exception reporting, change management, QC test materials maintenance,  reviewing and release documentation of COA.  This position will ensure that all local import testing related quality activities are in compliance with Corporate, governmental, local regulations and requirements and prioritized based on business needs. 

 
Key Responsibilities Include:
  • Ensure integration and support of quality regulations:  drug, biologics, and/or combination products.  Responsible for the design of effective importation QC test procedures and/or process within cross functional teams to ensure efficiency as well as compliance .      

  • Maintain a good working relationship with the government testing labs.

  • Evaluation of analytical data, methods and based upon knowledge and experience, disposition of product based upon testing results, specifications and requirements.

  • Oversight of laboratory investigations and CAPA knowledge.

  • Establishment and maintenance of procedures for the local activities related to QC testing in China by the local authority labs.

  • Internal auditing and maintenance of all QC testing related affiliate procedures including management of reference standards and laboratory supplies.  Support internal and external quality inspections and audits. 

  • Responsible for QC testing material management, including with ordering, payment, delivery and maintain inventory .

  • Coordination of test method transfers/validation, by working closely with the global and local stakeholders.

  • Scheduling of laboratory pre QC testing in alignment with business priority needs and utilization of resources.

 

 

 


 

  • Bachelor’s Degree in Chemistry, Biochemistry, Biology or equivalent science degree.   

  • 2-5 years’ of laboratory experience. 

  • Demonstrated management skills to deal effectively with laboratory personnel and areas serviced by the laboratory and other stakeholders

  • Strong analytical skills with ability to interpret laboratory data and take appropriate actions.  

  • Knowledge and familiarity with product, process, and both internal and external customer requirements. 

  • Strong knowledge of QA systems and GxP QA team, Regulatory/ National lab, Global functions compliance requirements including regulations and standards affecting biologics and pharmaceutical products preferred.  Ability to make operational and business decisions with minimal direction.  Budget management and finance acumen.

  • Strong knowledge of laboratory and quality control systems and requirements.   

  • Strong interpersonal, oral and written communication skills needed. 

  • Ability to manage across the enterprise.   

  • Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache, Attache Pro

 
Key Stakeholders:  Local Affiliate Staff, Commercial
 

 

Equal Employment Opportunity Employer

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.  As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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