Manager, Quality Engineering (357)

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-Engineering Manager 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. Responsibilities of the position include establishing and maintaining quality systems and compliance oversight to ensure the facility, utilities, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

The role is essential to assure the Petersburg site's validation and qualification programs comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.

Essential Duties and Responsibilities :

• Working across functions, to establish the site's quality system processes related to GMP compliance of the facility, utilities, equipment, and computer systems.
• Ensure the Quality oversight and review of validation and qualification activities for the site is performed including assurance that the appropriate resources, materials, and documentation are utilised, and that work is performed in a compliant and controlled manner.
• Provide leadership, direction, and support to the people within the Quality Assurance Engineering department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
• Support 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.
• Provide quality oversight for calibration and maintenance programs and ensure they are developed and run-in accordance with GMP regulation.
• Manage the quality risk management process.
• Support as needed process, method and cleaning validation.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
• Travel (up to 10%) may be required.

Basic Qualifications and Capabilities :

Preferred Qualifications :

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