Quality Assurance Manager
4 weeks ago
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to provide essential sterile injectable medications and combination products to patients in need.
Job Description:
The Quality Assurance (QA) Operations Manager will join our team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as our new fill finish facility dedicated to the manufacture and supply of essential sterile injectable medications and combination products.
Key Responsibilities:
Manage relationships with external partners for Quality Assurance needs. Liaison between external and internal stakeholders of Quality Assurance and Manufacturing Operations during technology transfer and manufacture of new products. Lead, approve documents and/or participate in change controls, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. Lead Quality Assurance manufacturing shop floor support to achieve smooth product transfer and ongoing manufacturing. Drive product and process changes to improve product quality. Review and aid in the establishment and maintenance of Quality Agreements Review and Approval of GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures and Technical Transfer Protocols. Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions. Lead or participate in Quality Risk Management and Data Governance Processes as needed. Lead pre-approval inspection readiness activities. Participate in activities to support regulatory agency inspections. Promote a quality mindset and quality excellence approach to all activities. Travel is limited but may occasionally be required.
Requirements:
8+ years' experience working directly with manufacturing in the sterile injectable pharmaceutical or medical device industries. Bachelor-level or higher education. Project management, organization, and execution skills are required. Ability to apply technical expertise to solve problems and issues. Experience with technology transfers and new product introduction. Knowledge of data integrity controls in a manufacturing setting. Familiarity with Annex 1 requirements. Participating in and leading activities that support regulatory agency inspections is 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.
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