Manager, Quality Assurance - OSD at Alkermes, Inc. in Wilmington, Ohio

Job Description:

Manager, Quality Assurance - OSD

Position Summary:

Accountable for quality assurance functions of oral solid dosage (OSD) 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 OSD operations at the Wilmington, Ohio site


• Provide oversight of the investigations and projects for OSD operations


• Provide consulting and SME support to the On the Floor QA Team OSD operations on compliance issues and troubleshooting


• 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 Qualifications:

• Bachelor's degree in a scientific discipline or equivalent


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


• Validation and 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:
Mid-Senior Level

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