Site Head of Quality and Compliance

Overview

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. 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 also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states. Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available.

CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage.

The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status. The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Join us. Learn more at www.civicarx.org

The Site Head of Quality and Compliance is an integral part of the Civica, Inc. ("Civica") leadership team in establishing and building the site team and infrastructure leading to the qualification and FDA approval of Civica’s fill finish manufacturing site for essential generic sterile injectable medicines. Responsibilities of the position include establishing and maintaining the Quality and Compliance policies, procedures, systems and oversight of the building and qualification of the manufacturing facility and ultimately the manufacturing, testing, packaging and release of quality essential medicines in accordance with Civica and U.S. Food & Drug Administration (FDA) regulations and expectations.

The Site Head of Quality and Compliance is responsible for the site Quality Management System, Quality Assurance and Quality Operations, and will be required to lead, develop and support compliance strategies and plans that meet CGMP, Drug Enforcement Administration (DEA) and all relevant governmental regulations and requirements applicable to the manufacture and distribution of human prescription drugs and devices. The Site Head of Quality must be able to
1) self-manage and work effectively with internal parties, external stakeholders, suppliers, and governmental agencies with very little direct oversight,
2) be responsible for establishing systems and assessing operations and identifying, prioritizing, and implementing actions to continuously improve operations and systems, and
3) report directly to the Civica, Chief Quality & Regulatory Affairs Officer with a dotted line reporting relationship to the Site Vice President and General Manager.

• Build and lead a high performing site Quality & Compliance team.
• Establish and implement the site Quality Management System, Quality Control Unit and Quality Assurance processes and procedures.
• Engage and collaborate on all site matters with the Site leadership staff under the direction of the Site Vice President and General Manager.
• Build and…