Associate Director Quality Assurance
1 day ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Founded in 2018 by health systems and philanthropies, Civica Rx aims to ensure the consistent availability of affordable medications.
With over 55 health systems on board, representing over 1,500 hospitals and 30% of all U.S. hospital beds, Civica Rx has made significant strides in addressing the issue of generic drug shortages. The organization 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.
Job DescriptionThe Associate Director, Quality Assurance - Engineering will play a crucial role in ensuring the quality and compliance of Civica Rx's operations. This position will be responsible for 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 Rx requirements.
Key Responsibilities- Provide leadership and direction to the Quality Assurance Engineering team to ensure they are qualified to achieve a high level of competence and motivated to carry out their duties in a safe manner.
- Establish and maintain quality system processes related to GMP compliance of the facility, equipment, computer systems, and manufacturing processes.
- Ensure quality oversight and review of validation and qualification activities and documentation for the site, including assurance that the appropriate resources, materials, and documentation are utilized, and work is performed in a compliant and controlled manner.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure 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 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.
- 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.
- 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.
- 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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