Associate Director, Quality Assurance Operations
4 weeks 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. Our team of experienced health care and pharmaceutical industry leaders is committed to ensuring the reliable supply of quality medicines to patients.
We are seeking an Associate Director, Quality Assurance Operations to join our team at our Petersburg, Virginia site. This individual will be responsible for establishing and maintaining quality systems and compliance oversight of manufacturing operations to ensure medications meet cGMP and Civica requirements.
Key Responsibilities- Lead the establishment and maintenance of quality systems compliance oversight related to manufacturing and packaging operations.
- Ensure all aspects of the handling, manufacturing, and distribution of pharmaceutical products comply with Civica and relevant cGMP regulatory requirements.
- Develop and implement quality assurance procedures to ensure the reliability and quality of our products.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
- Participate in and/or lead health authority inspections at the site.
- 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.
- Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
- Quality assurance management experience across the product development and commercialization lifecycle.
This is an exciting opportunity to join a dynamic team dedicated to improving the lives of patients. If you are a motivated and experienced quality professional looking for a new challenge, we encourage you to apply.
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Associate Director Quality Assurance Engineering
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Associate Director, Quality Assurance
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Associate Director, Quality Assurance
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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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