Associate Director, Quality Assurance Lead
4 weeks 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 provide essential generic sterile and biosimilar injectable medications to patients in need.
We are seeking an experienced Associate Director, Quality Assurance to join our team at our Petersburg, Virginia site. This individual 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.
The successful candidate will have a strong background in quality management, including experience in facility, utilities, and equipment qualification, computer and process validation, and calibration and maintenance programs for the manufacture of sterile injectable medications.
Key responsibilities will include providing leadership, direction, and support to the Quality Assurance Engineering team, ensuring compliance with regulatory standards, and participating in health authority inspections.
If you are a motivated and experienced quality professional looking to join a dynamic team, please submit your application.
Essential Duties and Responsibilities:
Provide leadership and direction to the Quality Assurance Engineering team
Establish and maintain quality systems and compliance oversight
Ensure compliance with regulatory standards, including cGMP and FDA requirements
Participate in health authority inspections and provide expert advice on quality-related matters
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
Provide quality oversight for calibration and maintenance programs
Participate in quality risk analysis/assessments and supplier assessments
Promote a quality mindset and quality excellence approach to all activities
Maintain written procedures for personnel qualification and training
Participate in and/or lead health authority inspections at the site
Basic Qualifications and Capabilities:
Bachelor's degree in a scientific discipline with a minimum of 14 years Quality/CGMP management experience
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
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
Excellent interpersonal and written communication skills and experience using various software/electronic applications
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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