Senior Quality Assurance Specialist

Senior Quality Assurance Specialist (Quality Systems)

Onsite - Minnesota (or site-based biotech environment)

Full-Time | Permanent

Work 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 reporting
• Develop and maintain risk management frameworks aligned with ICH Q9 and internal GMP procedures
• Lead structured risk assessments (FMEA, risk matrices) across processes, products, and systems
• Communicate risk findings and mitigation strategies to cross-functional stakeholders and leadership
• Track and drive closure of action items from management review outputs

Change Control Management:

• Own the end-to-end change control process, including initiation, impact assessment, approvals, and closure
• Evaluate regulatory and quality impact of proposed changes in accordance with 21 CFR 210/211 requirements
• Partner with Manufacturing, R&D, Regulatory, and Validation teams to ensure compliant implementation of changes
• Maintain and improve SOPs and workflows within an electronic Quality Management System (eQMS)
• Train and support teams on change control processes and best practices

Quality Metrics & Performance Monitoring:

• Define and maintain quality KPIs, including CAPA cycle time, deviation trends, audit findings, and change control aging
• Develop quality dashboards and trend reports for leadership review
• Identify adverse trends and proactively escalate with recommended corrective actions
• Support annual product reviews and periodic quality system evaluations
• Improve reporting tools using platforms such as Excel, Power BI, and eQMS systems

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Biology, or related field (required)
• 5 years of QA experience in a GMP pharmaceutical or biotech environment
• Strong 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 requirements
• Experience with data analysis and reporting tools (Excel, Power BI preferred)
• Strong communication skills with ability to present data to leadership
• Highly detail-oriented with strong documentation and compliance mindset

What’s Offered:

• Competitive compensation aligned to experience
• Annual performance bonus
• Comprehensive benefits package including:
• Medical, dental, and vision insurance
• Paid time off and holidays
• Life insurance disability coverage
• Retirement plan with employer match (Simple IRA)
• Opportunity to join a fast-growing biotech environment focused on cutting-edge science

Important:

• This role is onsite-based
• Visa sponsorship is not available