Associate Director, Quality Assurance - Engineering (215) at Civica in Petersburg, Virginia

Job Description:

About Civica:



Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.


Shortages put patients at risk and waste hospital resources.


Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.


Civica's mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.


Civica's new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.


The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica's work to manufacture and distribute affordable medications. The Foundation's first commitment is to support Civica's efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.


Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.


Join us. Learn more 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.

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