Associate Director, Quality Assurance – Engineering

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 combat these 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 prioritize patient interests.

Civica has expanded its mission to include reducing pharmacy medication costs through its sister organization, CivicaScript. Recently, they announced plans to produce affordable biosimilar insulin, ensuring consistent access for those in need.

Job Description:

The Associate Director, Quality Assurance – Engineering will oversee quality systems at Civica’s Petersburg, Virginia site, dedicated to manufacturing essential sterile and biosimilar injectable medications. Responsibilities include ensuring compliance with cGMP standards, maintaining quality oversight, and supporting validation and qualification processes.

Essential Duties and Responsibilities:

• Lead and support Quality Assurance Engineering and other departments.
• Establish and maintain quality system processes for GMP compliance.
• Oversee validation and qualification activities and documentation.
• Stay updated on regulatory requirements and provide expert advice.
• Support compliance of product transfers and ensure overall facility compliance.
• Lead operational readiness for Health Agency inspections.
• Manage quality processes across the product lifecycle.
• Ensure calibration and maintenance programs meet GMP regulations.
• Participate in quality risk assessments and supplier qualifications.
• Promote a quality and safety mindset in all operations.
• Maintain training procedures and support compliance training.
• Participate in health authority inspections.
• Travel (up to 10%) may be required.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with 14+ years of Quality/CGMP management experience, including 7 years in a supervisory role.
• Experience with FDA and EMA requirements for sterile injectables.
• Technical expertise in sterile pharmaceutical isolator technology is desirable.
• Strong project management and organizational skills.
• Experience supporting regulatory agency inspections.
• Excellent communication skills and proficiency in software applications.
• Ability to synthesize data and provide compliant recommendations.
• Self-motivated and adaptable in a dynamic environment.
• Committed to delivering high-quality results and overcoming challenges.