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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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Manager, Quality Labs (Microbiology)
Branchburg Township, New Jersey Req ID 2209629 Category Quality Assurance Division AbbVie- Implement, monitor and maintain the Quality system areas assigned. Assure quality process and procedures are effective and in compliance with the regulations. Support internal/external Regulatory inspections.
- Prepare, review and approve Quality system records. Makes decisions that may affect product disposition or have adverse consequences on the Quality system.
- Lead a group of professional responsible of the quality activities execution. Provide guidance and quality expertise.
- Lead Quality Plan and Improvement projects. Responsible for planning, implementation, tracking and reporting of the Quality plan projects and strategic initiatives at the site.
- Perform assessments to determine compliance to processes and regulation. Identify gaps a mitigate and implement improvements
- Coordinate and support Quality Reviews with executive management. Assure that the actions are assigned ,tracked and completed .
- Provide direction to ensure sources of product and quality problems are identified. Provide leadership to ensure that CAPA actions are adequate and implemented in a timely manner.
- Provide consultation and training on Quality expertise to internal and cross functional groups.
- Review Technical information provided to support the Quality system. Assure that the correct techniques and tools are used.
- Advocate for continual improvement of operations and Quality system.
- Bachelor's degree in Science(Chemistry, Pharmacy, Biology , Microbiology , Engineering or other technical/scientific area) . Master degree is desirable.
- Eight (8) years minimum experience in quality assurance, technical field on a regulated industry or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, process technology, manufacturing operations, project management.
- Possess excellent communication and negotiation skills.
- Comprehensive knowledge and application of business and quality concepts.
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