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Quality Manager, Global Serum Business

 

We are looking for a Quality Manager for our Serum Product business in Lenexa which will be managed on a global basis. The Global Serum Quality team is responsible for working with the Global Serum Business and providing overall quality management and oversight on a global basis for the sourcing and supply of serum products into our markets.

 

Your role:

This position will be responsible for providing the overall management and leadership for the Global Serum Quality function and initiating/providing the daily quality activities needed to run the global serum business.  This will also include working closely with the Serum Business Unit and Supplier Quality Teams to define, qualify and maintain the Quality system(s) and associated supply chain(s) as required to and appropriate for the serum products sold in the Research, Applied and Process Solutions markets on a global basis.  Specific activities will include but are not limited to the following:

 

  • Provide overall Quality leadership and direction for the serum business on a global basis.
  • Provide Quality management to investigate, assess and resolve any quality issues with our raw serum suppliers or serum contract manufacturing organizations (CMOs).
  • Responsible for ensuring all testing and documentation meets specified requirements and then for the release of raw serum lots and final product lots from suppliers and CMO’s globally.
  • Responsible for approval and generation as required of all label print, batch documentation and supporting certifications, such as; CofI’s, CofA’s, CofM’s and any other required supporting documentation for serum products.
  • Initiate and coordinate additional product testing as required to meet Customer requirements at outside labs or within the network.
  • Provide guidance and assistance in the set-up and approval of; product specifications, new products and serum specific Quality Agreements.
  • Provide Leadership for the Serum Quality Review Board meetings and activities including serum complaint management.
  • Provide oversight and coordination with the Supplier Quality Management functions along with the Biological Materials Group to ensure overall compliance to internal and external customer’s needs and requirements.
  • Participate in Global Serum Business meetings and activities.
  • Take part in and contribute to a safe working environment by following corporate and departmental safety regulations.
  • All other job-related duties and activities as assigned.

     

    Who You Are:

     

  • Bachelor’s Degree in Life or Physical Science with 7-10 years related experience and 3-5 years of supervisory experience, or equivalent combination of education and work experience in a GMP environment.
  • Ability to interpret laboratory results as it impacts products, which requires a good understanding of microbiology.
  • Basic budgetary planning, capital expenditure justification, and basic finance, accounting, marketing and operations management.
  • Demonstrated people management skills including strong interpersonal skills with ability to act as a mentor to staff and co-workers.
  • Experience in a leadership role including fast-paced environment.
  • Excellent oral and written communication skills.
  • Experience with the application of cGMP, ISO, and FDA regulations in a manufacturing environment, to include auditing practices and procedures plus having auditing skills.
  • Proficient computer skills, including MS Office suite of products.
  • Ability to organize tasks effectively with good time management and multi-tasking capabilities.

    PREFERRED:

  • Working industry knowledge of FDA, ISO, USDA and EU regulations.
  • Previous experience managing the development and maintenance of quality systems.

     

     

Job Requisition ID:  186590
Location:  Lenexa
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Nearest Major Market: Kansas City

Job Segment: Microbiology, Quality Manager, Manager, Science, Quality, Management, Research

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