Associate Director, Quality Assurance

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 - Engineering 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 to ensure the validation/qualification and operation of processes, facility, equipment, and computer systems meet cGMP and Civica requirements at the onset of building and qualifying 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. Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of validation, qualification and ongoing verification and operational activities of facility, utilities, process, equipment, instrumentation meet or exceed Health Agency requirements.

Essential Duties and Responsibilities:

• Provide leadership, direction, and support to the people within Quality Assurance Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Establish and maintain the site's quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes by working across functions.
• Ensure the Quality oversight and review of validation and qualification activities and documentation 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.
• 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.
• Ensure implementation and quality oversight related to the overall compliance of the facility, utilities, equipment, and manufacturing processes.
• Lead operational and inspection readiness for Health Agency inspections.
• 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.
• Participate or lead in quality risk analysis/assessments.
• Participate or lead the assessment, qualification, and approval of suppliers.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Lead and participate in 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 including 7 years in a supervisory role in the pharmaceutical industry. Experience in facility, utilities and equipment qualification, computer and process validation and calibration and maintenance programs for the manufacture of sterile injectable medications.
• 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, 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
• Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Quality management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
• Participation and leading activities to support regulatory agency inspections (FDA/EMA) required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
• Ability to collaborate and manage conflict in a fast-paced environment.
• 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.