Associate Director, Validation

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 mission prioritizes patient welfare.

Recently, Civica launched CivicaScript to reduce pharmacy costs and announced plans to produce affordable biosimilar insulin, ensuring consistent access for those in need.

Job Description

The Associate Director of Validation will lead the Validation function at the Petersburg, VA site, developing and implementing validation strategies and overseeing Commissioning, Qualification, and Validation activities.

Essential Duties:

• Develop and maintain the Validation Master Plan.
• Contribute to strategic initiatives as part of the site leadership team.
• Implement validation policies per regulations and industry standards.
• Oversee SOPs, protocols, and reports for cGMP equipment and processes.
• Manage cleaning validation programs using a risk-based approach.
• Lead Aseptic Processing Simulation and Air Visualization Studies.
• Support Change Control and Tech Transfers for validation activities.
• Mentor and train validation staff.
• Collaborate with cross-functional teams to drive validation deliverables.
• Serve as a subject matter expert in validation.
• Participate in regulatory inspections as an SME.
• Ensure data integrity and compliance with Part 11/Annex 11.
• Manage departmental budget and resources effectively.
• Promote a culture of continuous improvement and safety.

Basic Qualifications:

• Bachelor’s degree or similar technical degree required.
• 10+ years of experience in validation within the pharmaceutical industry.
• 7+ years of expertise in validation execution.
• 3+ years as a primary SME during regulatory inspections.
• Experience in sterile manufacturing and cGMP environments.
• Knowledge of CQV, cleaning validation, and aseptic process simulations.
• Strong communication skills and project management capabilities.

Preferred Qualifications:

• Expertise in high-speed aseptic filling and barrier systems.
• Experience with process validation and capital project management.
• Knowledge of Computerized Systems Validation (CSV).
• Familiarity with continuous improvement tools like Six Sigma.