QA Compliance Specialist II (360)
Civica

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress 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.

• 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.

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