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Associate Director, Quality Assurance Job in Wilmington, Ohio US

Associate Director, Quality Assurance

Alkermes, Inc. - Wilmington, OH

Posted: 5/11/2021 - Expires: 8/9/2021

Job ID: 227138965

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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.

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 Experience Level:
Director

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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Identified Skills


Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
50713111_1
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A