Quality Assurance Operations Supervisor

About Civica

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.

Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description

The QA Operations 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.

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.