Associate Director, Quality Assurance - Operations 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 Associate Director, Quality Assurance - Operations will join the Civica, Inc. ("Civica") organization and the 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 and biosimilar injectable medications. Responsibilities of the position include establishing and maintaining quality systems and compliance oversight of manufacturing operations to ensure medications manufactured meet cGMP and Civica requirements at the onset of manufacturing exhibit batches through validation and ongoing supply. Responsibilities also include supporting pre-approval and inspection readiness activities resulting in 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 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, batch disposition, review and approval of deviation investigations and change controls, 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 that meet or exceed Health Agency requirements.

Essential Duties and Responsibilities:

• Provide leadership, direction, and support to the people within the Quality Assurance Operations and other department to ensure that they are qualified to achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Lead the establishment and maintenance of the site's quality systems compliance oversight related to manufacturing and packaging operations to enable the development and reliable supply of quality sterile medications to patients.
• Responsible for all operational compliance aspects of sterile fill finish manufacturing of medications including but not limited to batch record, change control and deviation investigation review, batch disposition, and shop-floor quality.
• Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products at the site comply with Civica and relevant cGMP regulatory requirements.
• Ensure Standard Operating Procedures, and training is in place to maintain compliance with cGMP through QA shop-floor support.
• Maintain current knowledge of 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.
• Lead operational inspection readiness activities by working across functions.
• Support and ensure compliance of equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.
• Responsible for ensuring raw materials, excipients, APIs and components are qualified and their suppliers are approved in accordance with Civica and GMP requirements.
• Responsible for ensuring 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 or lead quality risk analysis/assessments.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Lead deviation investigations as necessary.
• 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.
• Participate in and/or lead health authority (primarily FDA and E.U.) agency inspections at the site.
• Travel (up to 10%) may be required.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Basic Qualifications and Capabilities:

• Bachelor's degree in a scientific discipline with a minimum of 14 years Quality/CGMP management experience in the pharmaceutical industry. Extensive experience in sterile injectable manufacturing and packaging operations is required.
• Knowledge and experience in translating FDA and European Medicines Agency (EMA) requirements and guidance into operations success including but not limited to Annex 1 requirements for sterile injectable medications.
• Participation and leading activities to support regulatory agency inspections required.
• Prior experience leading and participating in FDA/EMA inspections.
• Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Quality assurance management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
• Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
• Ability to collaborate and manage conflict in a fast-paced environment.
• Minimum of 7 years' experience in a supervisory role.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, start-up, and dynamic environment.
• Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.