Associate Director, Quality Assurance Operations
2 days ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Established in 2018 by health systems and philanthropies, Civica Rx aims to ensure the consistent availability of affordable medications for patients.
Job DescriptionThe Associate Director, Quality Assurance - Operations will join the Civica Rx team at our Petersburg, Virginia site, bringing expertise in quality systems and compliance oversight to ensure the manufacture and supply of essential generic sterile and biosimilar injectable medications meet cGMP and regulatory requirements.
Key Responsibilities- Establish and maintain quality systems and compliance oversight of manufacturing operations to ensure medications meet cGMP and regulatory requirements.
- Support pre-approval and inspection readiness activities to ensure successful FDA approval of the facility and introduction of new medications.
- Lead operational inspection readiness activities, working across functions to ensure compliance with regulatory standards.
- Ensure raw materials, excipients, APIs, and components are qualified and suppliers are approved in accordance with GMP requirements.
- Responsible for quality shop-floor oversight, including real-time batch record review, response to deviations, and implementation of corrective actions.
- Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations.
- Bachelor's degree in a scientific discipline with a minimum of 14 years Quality/CGMP management experience in the pharmaceutical industry.
- Extensive experience in sterile injectable manufacturing and packaging operations is required.
- Knowledge and experience in translating FDA and European Medicines Agency (EMA) requirements and guidance into operations success.
- Participation and leading activities to support regulatory agency inspections required.
- Prior experience leading and participating in FDA/EMA inspections.
Civica Rx offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to delivering high-quality results and working collaboratively to overcome challenges.
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Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to affordable, high-quality medications.Job Description:Associate Director, Quality Assurance - OperationsWe are seeking an experienced...
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Petersburg, United States Civica Rx Full timeAbout Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...
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