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Quality Assurance Manager
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. Founded in 2018 by health systems and philanthropies, Civica Rx aims to ensure the consistent availability of affordable medications.
Job Description:The Quality Document Control and Training Manager will play a critical role in ensuring the Petersburg site's document control and training management system complies with applicable regulatory standards. This includes leading the quality document control and training team, developing quality systems and processes, and overseeing document controls and training management.
Essential Duties and Responsibilities:- Manage and oversee day-to-day activities associated with document control, records retention, batch record management, and training.
- Lead the establishment and maintenance of the site's quality system framework, including quality systems related to document control, batch record issuance and control, and training.
- Develop and/or improve quality processes and systems.
- Track, trend, and analyze quality system data and information for the site.
- Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- Manage and develop personnel.
- Promote a quality mindset and quality excellence approach to all activities.
- Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
- Maintain current knowledge of FDA and Civica requirements to keep pace with evolving regulations and requirements.
- Participate in activities to support regulatory agency inspections.
- 8 years' experience in pharmaceutical or medical device industries.
- Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
- Quality system management experience.
- Minimum of 3 years' experience in a supervisory role.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills, and share knowledge with others.
- Experience in Veeva Quality Management Systems.
