This job listing has expired and the position may no longer be open for hire.

Associate Director, Quality Assurance at Alkermes, Inc. in Wilmington, Ohio

Posted in Other 30+ days ago.





Job Description:

Associate Director, Quality Assurance



Position Summary:


Accountable for quality assurance functions of all manufacturing operations at the Wilmington, Ohio site. Ensure that the site operates in compliance with FDA, EU and all other regulations as demanded by our customers and remains inspection ready at all times. Interface with FDA, other regulatory agencies, customers and consultants.



Primary Responsibilities:



  • Direct the daily activities quality assurance functions of all operations at the Wilmington, Ohio site

  • Provide oversight of decisions and actions that may impact the SQIPS of final product and all supporting functions in operations

  • Ensure that resources are staffed appropriately, and the required initial and continuing education of personnel is carried out and adapted according to need

  • Proactively participate in Quality Culture initiatives, continuous improvement efforts and implementing policy as part of QA leadership team



Required Education/Experience:



  • Bachelor's degree in a scientific discipline or equivalent

  • 10+ years experience in a cGMP manufacturing environment with a biotech or pharmaceutical company, a significant portion of which needs to have been in QA

  • Validation and Parenteral and/or Oral Solid Dosage experience is essential

  • Experience in developing and implementing a CGMP compliance program in association with bringing a product through clinical trials to commercialization



Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.


#LI-DB1

Experience Level:
Director

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