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Associate Director, Quality Assurance
2 months 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. Our mission is to ensure that patients have access to essential medications at affordable prices.
Job Description:Associate Director, Quality Assurance - EngineeringWe are seeking an experienced Associate Director, Quality Assurance - Engineering to join our team at our Petersburg, Virginia site. As a key member of our quality team, you 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 requirements.
Key Responsibilities:
- Provide leadership, direction, and support to the quality team to ensure they are qualified to achieve a high level of competence and 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.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure expert advice and 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.
- 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.
- 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 and supplier assessments.
- 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.
Requirements:
- Bachelor's degree in a scientific discipline with a minimum of 14 years of 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 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) is required.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications are 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.
