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Civica - Petersburg, VA
posted 3 months ago
About the position
The Quality Assurance (QA) Manager - GXP Computer Systems at Civica will oversee the Computerized System Validation (CSV) of GXP Computerized Systems, ensuring compliance with regulatory standards and quality assurance practices. This role is critical in supporting Civica's mission to provide essential generic and biosimilar medicines by ensuring that all computerized systems meet the necessary quality and regulatory requirements. The QA Manager will collaborate with various teams to implement and maintain quality management systems and will be responsible for leading validation efforts and ensuring data integrity across systems.
Responsibilities
- Provide QA leadership for GXP computer systems and ensure compliance with 21 CFR Part 11 and GAMP 5.
- Support the readiness of the CSV program and ensure software programs are compliant for audits and inspections.
- Review and assess proposed GXP-related computer system change controls and investigations.
- Review and approve validation plans, protocols, and reports for GXP computer systems.
- Assess systems for data integrity and compliance with regulatory expectations.
- Participate in the external audit program for vendors related to GXP computerized systems.
- Provide QA guidance in the development of GXP computer system procedures.
- Participate in cross-functional project teams for GXP computer system compliance.
- Collaborate with system owners to address priorities for GXP computer system configuration and security.
- Perform quality support duties in the Veeva quality management system.
Requirements
- Bachelor's Degree in Scientific discipline, Computer Science, or Information Technology; Master's preferred.
- 8+ years of relevant progressive experience in the pharmaceutical/biotech industry.
- Comprehensive expertise in GXP requirements including 21 CFR Parts 11 and ISPE GAMP 5.
- Preferred experience in validation for SaaS systems.
- Proven business and technology skills in providing customer-oriented technology solutions.
- Advanced skills in Microsoft Office, especially Excel, Word, PowerPoint, and Outlook.
- Excellent verbal and written communication skills.
- Ability to read and follow complex instructions.
- People-oriented with a collaborative work style.
- Analytical thinker with excellent problem-solving skills.
- Strong planning, organization, and time management skills.
Nice-to-haves
- Experience with Veeva Vault and other GXP-related software applications.
- Familiarity with regulatory inspections and audit processes.
Benefits
- Competitive salary based on experience.
- Remote work flexibility with occasional travel required.
