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Site Head of Quality

Your role:

 

Responsible for managing the Quality Assurance, Quality Control and Validation Departments for the Lenexa Site Operations.  Assuring all Quality systems and programs are in place to achieve and maintain compliance with ISO standards and cGMP requirements as appropriate to meet customer needs and expectations.  Represents company in interactions with customers and governmental agencies to ensure regulatory requirements and customer expectations are met.  Is a key member of the Site Leadership Team providing overall guidance and leadership for the site to achieve site goals and initiatives.

 

 

 

Who you are:  

 

  • Bachelor Degree in a scientific discipline required; Advanced degree strongly preferred.
  • Minimum 5 years Quality Management experience in a cGMP regulated industry with a Bachelor Degree; 3 years with advanced degree.
  • Thorough understanding of ISO Standards and cGMP requirements Biologics.
  • Thorough understanding of analytical techniques.
  • Strong leadership skills with proven ability to manage a manufacturing site.
  • Excellent written and verbal communications skills.
  • Ability to act as a mentor to staff and co-workers and act as a proven agent of change.
  • Experience in managing inspections by regulatory agencies (FDA, EMEA, etc.).
  • Proven team building, mentoring and personnel development skills.
  • Thorough knowledge of Project Management and Process Improvement skills.  Six Sigma/Lean Manufacturing qualification desirable.
     

     
Job Requisition ID:  190947
Location:  Lenexa
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Kansas City

Job Segment: Quality Manager, Lean Six Sigma, QC, QA, Quality, Management

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