QA Compliance Specialist II (360)

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 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. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Job Description:

The Quality Assurance (QA) Compliance Specialist II will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance.  The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. 

Lead aspects of quality and compliance to ensure compliance with applicable regulatory standards (e.g., 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.   

Essential Duties and Responsibilities:

• Working across functions, participate in the implementation and maintenance of the site’s quality system framework including quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients.
• Implement, track, trend, and analyze quality processes and systems across the product lifecycle including, but not limited to, 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 risk-based and compliant approaches to solutions.
• Working across functions to 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 a minimal amount of 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.

Basic Qualifications and Capabilities:

• 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 are required.
• Ability to apply technical expertise to solve problems and issues.
• Participating in and leading activities that support regulatory agency inspections is required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.

Preferred Qualifications:

• Experience with Veeva.
• Yellow belt or other belt certification.