Sr. Manager, Quality Assurance and GXP System
13 days ago
San Diego
Job Description Job Summary: Manages the Quality Management System (QMS) and actively supports the implementation and maintenance of GxP electronic systems, including Electronic QMS (EQMS), Electronic Trial Master File (eTMF), and Regulatory Information Management (RIM) systems. Responsible for overseeing change control activities, training, SOPs, and SOP deviations within the EQMS. Prepares quality metrics and reports and provides document support for regulatory filings. Oversee data integrity within electronic systems ensuring activities performed are compliant with the quality management system and FDA and EU regulations and other applicable laws or guidelines. Responsibilities 1. EQMS Management and Optimization • Manage and organize existing quality documents within the EQMS., • Manage the controlled documents lifecycle (SOPs, policies, work instructions) within the EQMS., • Drive harmonization of electronic document templates and metadata standards for quality documents., • Ensure robust training program integration with EQMS; monitor completion and effectiveness., • Identify opportunities to streamline workflows and enhance EQMS user experience. 2. Automation, Reporting, and Metrics • Implement automation and reporting tools for key performance indicators (KPIs) (e.g., training compliance, document cycle times)., • Prepare metrics and continuously track the status of compliance risk related to training and other controlled documents and report to management., • Establish Inspection Readiness activities and metrics; generally serve as primary point of contact for providing documents during audits and inspections. 3. Cross-Functional Collaboration • Partner with Regulatory, Clinical, QA, and IT teams to align system capabilities with business needs., • Assist departments to develop department-specific controlled documents, GxP core training, and training matrices., • Ensure systems meet requirements for Computer Systems Validation (FDA 21 CFR Part 11, EU EMA Annex 11, ISO 13485, ICH E6) working with IT, QA, Clinical, and Regulatory departments. 4. Regulatory and Audit Support • Support internal/external audits and regulatory inspections; provide system data and reports., • Manage GxP-related documents for regulatory filings, as required. 5. Document Control and Compliance • Manage uploads and storage of GMP Contract Manufacturing Organization (CMO) Master Batch Records (MBR), Executed Batch Records (EBR), contractor manuals, Quality Agreements (QAGs), and documents from third-party service providers such as Good Clinical Practice (GCP) Contract Research Organization (CROs) and GXP contract testing laboratories (CTLs). Education: BA/BS degree required; preferably in a science-related field. Qualifications And Requirements: • Minimum 7 years of experience within the biopharmaceutical industry in a GxP environment of which 3+ years must be in Quality Systems management., • Excellent organizational, written, and verbal communications., • Hands-on experience with Veeva Vault (RIM, eTMF) and EQMS platforms., • Strong knowledge of GxP regulations, FDA 21 CFR Part 11, ISO standards., • Expertise in document control, training systems, and audit readiness., • Excellent communication and stakeholder management skills., • Proficient with MS Office applications (Word, Excel, PowerPoint, and Visio) required., • Experience in the implementation/maintenance of electronic document management systems, curriculum design, and training is desirable., • Ability to author, edit, format, and critically review controlled documents and SOPs., • Experience overseeing document uploads related to CMOs, CROs, investigator sites, and other clinical service providers is preferred., • Strong critical thinking, problem-solving, influencing, and exceptional attention to detail., • Ability to multi-task, prioritize options, anticipate challenges, and execute goals as an interdisciplinary global team member is essential., • Experience in system validation and change control for Software as a Service (SaaS) platforms preferred., • Ability to lead cross-functional projects and vendor relationships.