Quality Assurance Operations Supervisor (369) at Civica Rx

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 QA Operations Supervisor 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. 

The role is essential to assure the Petersburg site’s manufacturing and operations activities 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. 

Responsibilities also include, but are not limited to, shop floor oversight and the generation, review and/or approval of policies, procedures, reports, batch records and other records necessary to support the design, implementation, and maintenance of manufacturing processes for insulin, biologics or biosimilar medicines that meets or exceed FDA requirements.  

Essential Duties and Responsibilities:

• Working across functions, establish and maintain the site’s quality systems related to insulin, biologics and biosimilar manufacturing operations to enable reliable supply of quality medications to patients.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Responsible for operational compliance aspects of sterile fill finish manufacturing of products including but not limited to aseptic process simulations, terminal sterilization, batch record review and shop-floor quality. 
• Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Establish and maintain Standard Operating Procedures and training   consistent with CGMPs for QA shop-floor support.    
• Provide leadership, direction, and support to ensure shop floor associates and operators are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions. 
• Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
• Support, review and approve equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.
• Establish and maintain Standard Operating Procedures, and training to ensure raw materials, excipients, APIs and components are qualified and their suppliers are approved in accordance with Civica and GMP requirements. 
• Establish and maintain Standard Operating Procedures, and training to ensure that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labelling and drug products are released in accordance with the registered specifications.
• Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.
• 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.
• Participate in quality risk analysis.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Travel limited but may occasionally be required.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry.  Experience in sterile injectable manufacturing and packaging operations is required.
• Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.
• Supervisory experience.
• Quality assurance experience across the product development and commercialization lifecycle including.
• Participation and leading activities to support regulatory agency inspections 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:

• Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
• Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
• Prior experience in a supervisory role highly desired.