Senior Quality Assurance Specialist

Senior Quality Assurance Specialist (Quality Systems)Onsite - Minnesota (or site-based biotech environment)Full-Time | PermanentWork with a growing biotechnology organization focused on advancing next-generation therapies across cell therapy, gene therapy, and viral vector platforms. The team is science-driven, highly collaborative, and committed to developing innovative solutions that directly support breakthrough research in oncology and rare disease.We are seeking a Senior Quality Assurance Specialist Quality Systems to take ownership of core Quality System processes and play a key role in strengthening compliance, inspection readiness, and continuous improvement across a GMP-regulated environment. This is a high-visibility, systems-focused QA role working cross-functionally with Manufacturing, R&D, and Regulatory teams to ensure robust, scalable quality infrastructure.Key Responsibilities Include:Quality Systems & Risk Management:Facilitate and support Management Review meetings, including preparation of quality data, agendas, and executive-level reportingDevelop and maintain risk management frameworks aligned with ICH Q9 and internal GMP proceduresLead structured risk assessments (FMEA, risk matrices) across processes, products, and systemsCommunicate risk findings and mitigation strategies to cross-functional stakeholders and leadershipTrack and drive closure of action items from management review outputsChange Control Management:Own the end-to-end change control process, including initiation, impact assessment, approvals, and closureEvaluate regulatory and quality impact of proposed changes in accordance with 21 CFR 210/211 requirementsPartner with Manufacturing, R&D, Regulatory, and Validation teams to ensure compliant implementation of changesMaintain and improve SOPs and workflows within an electronic Quality Management System (eQMS)Train and support teams on change control processes and best practicesQuality Metrics & Performance Monitoring:Define and maintain quality KPIs, including CAPA cycle time, deviation trends, audit findings, and change control agingDevelop quality dashboards and trend reports for leadership reviewIdentify adverse trends and proactively escalate with recommended corrective actionsSupport annual product reviews and periodic quality system evaluationsImprove reporting tools using platforms such as Excel, Power BI, and eQMS systemsQualifications:Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Biology, or related field (required)5+ years of QA experience in a GMP pharmaceutical or biotech environmentStrong experience managing Quality Systems (change control, risk management, or metrics)Hands-on experience with eQMS platforms (Veeva Vault, MasterControl, Qualio, or similar)Strong understanding of FDA 21 CFR 210/211, ICH Q9, ICH Q10, and GxP requirementsExperience with data analysis and reporting tools (Excel, Power BI preferred)Strong communication skills with ability to present data to leadershipHighly detail-oriented with strong documentation and compliance mindsetWhat’s Offered:Competitive compensation aligned to experienceAnnual performance bonusComprehensive benefits package including:Medical, dental, and vision insurancePaid time off and holidaysLife insurance + disability coverageRetirement plan with employer match (Simple IRA)Opportunity to join a fast-growing biotech environment focused on cutting-edge scienceImportant:This role is onsite-basedVisa sponsorship is not available