QA Compliance Specialist II

About Civica

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all‑time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market‑based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages.

Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one‑third of all U.S. hospital beds. Civica has supplied the U.S. Department of Veterans Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines and currently supplies medicines in 49 states. Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, dedicated to making quality outpatient generic medicines affordable and available.

CivicaScript works with trusted manufacturing partners, payors, pharmacy benefit managers and pharmacies to enable significant cost savings to customers. Civica’s new 140,000 square‑foot state‑of‑the‑art manufacturing facility in Virginia will produce a steady supply of more than three dozen sterile injectables, all drugs currently in or near shortage, and affordable biosimilar insulins.

The Civica Foundation is a 501(c)(3) organization fostering philanthropic support to bring affordable insulin to all Americans. Civica is leading a movement for patients, not profits, because eliminating shortages and stabilizing high prices are in the best interest of patients. Join us. Learn more at www.civicarx.org
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The Quality Assurance (QA) Compliance Specialist II will join Civica’s newly forming team at the Petersburg, Virginia site. The role will lead aspects of quality and compliance to ensure compliance with applicable regulatory standards (Current Good Manufacturing Practices, Good Distribution Practices), internal standards and expectations for the development and reliable supply of quality medicines. Responsibilities include leading activities related to supplier qualification, change control, investigations and CAPA, complaints, Quality Risk Management, inspection readiness and metrics.

• Participate in implementation and maintenance of the site’s quality system framework and processes necessary to enable the development and reliable supply of Civica generic medications.
• Implement, track, trend, and analyze quality processes and systems across the product lifecycle including change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
• Lead the assessment, qualification, and approval of suppliers.
• Participate in or lead internal self‑assessment audits.
• Proactively identify and work collaboratively to resolve problems taking a risk‑based and compliant approach to solutions.
• Ensure compliant document control and training programs.
• Lead or participate in Quality Risk Management and Data Governance Processes as needed.
• Participate in activities to support regulatory agency inspections.
• Support site objectives with minimal supervision. Includes simple project management that may involve other functional areas.
• Promote a quality mindset and quality excellence approach to all activities.
• Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
• Travel is limited but may occasionally be required.

• 6+ years’ experience working directly with manufacturing in the pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor‑level or higher education.
• Demonstrated experience conducting and writing compliance and/or risk assessments.
• Project management, organization, and execution skills.
• Ab…