Quality Assurance Manager – GPV and Clinical

Job Description

About Civica:

In the last 20 years, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to alleviate chronic drug shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. Their guiding principle is to “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission to include reducing pharmacy costs through its sister organization, CivicaScript, and is developing affordable biosimilar insulin to support those in need.

Job Description:

The Quality Assurance (QA) Manager – Global Pharmacovigilance (GPV) and Clinical will oversee pharmacovigilance and product quality functions, ensuring compliance with cGMP and GCP standards for Civica’s generics and biosimilars.

Essential Duties:

• Lead pharmacovigilance and product quality complaint functions, ensuring compliance with FDA regulations.
• Oversee clinical study processes and ensure investigational drugs are shipped only to qualified investigators.
• Communicate compliance requirements and manage awareness of deviations or issues.
• Review regulatory filings and assess changes to compliance requirements.

Qualifications:

• Bachelor’s degree in Science, Nursing, or PharmD.
• 7+ years in the pharmaceutical industry, with leadership experience in GCP quality assurance.
• Strong knowledge of ICH/GCP and regulatory guidelines.
• Excellent communication and problem-solving skills.

For more information, visit www.civicarx.org.