Civica Rx · 11 hours ago
Manager, Quality Engineering (357)
Petersburg, VA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expCivica Rx is a social welfare organization focused on reducing drug shortages and high medication prices in the United States. The Quality Assurance-Engineering Manager will establish and maintain quality systems and compliance oversight for Civica's Petersburg facility, ensuring adherence to regulatory standards and the successful introduction of new medications.
Pharmaceutical
Responsibilities
Working across functions, to establish the site’s quality system processes related to GMP compliance of the facility, utilities, equipment, and computer systems
Ensure the Quality oversight and review of validation and qualification activities 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
Provide leadership, direction, and support to the people within the Quality Assurance Engineering department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe 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
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
Manage the quality risk management process
Support as needed process, method and cleaning validation
Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions
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
Travel (up to 10%) may be required
Qualification
Required
Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry
Experience in facility, utilities and equipment qualification, computer validation and calibration and maintenance programs
Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required
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 required
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
Preferred
Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable
Process, method and cleaning validation
Company
Civica Rx
Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.
51-200 employees
H1B Sponsorship
Civica Rx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (2)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$3M2025-08-07Grant· $3M
Leadership Team
Ned McCoy
CEO
Dave Sehgal
Chief Manufacturing and Supply Chain Officer
Recent News
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