Senior Quality Systems Lead

Senior Quality Systems Lead

Industry: Pharmaceutical/Biotechnology

Location: Rochester, MN

Employment Type: Full-Time | Direct Hire

Compensation: $95,000 – $110,000 (Commensurate with experience)

About the Role

Seeking an experienced and detail-oriented Senior Quality Systems Lead to join our Pharmaceuticals/Biotech Quality Assurance team. This pivotal role is responsible for maintaining and continuously improving core quality programs, including Management Review, Risk Management, Change Control, and Quality Metrics.

The ideal candidate brings a proactive mindset, strong GMP knowledge, and the ability to collaborate cross-functionally within a highly regulated environment.

Key Responsibilities

Management Review & Risk Management

• Facilitate Meetings: Coordinate periodic Management Review meetings, including the preparation of agendas, data packages, and official minutes.
• Risk Frameworks: Develop and maintain risk management frameworks aligned with ICH Q9 and company SOPs.
• Assessments: Lead risk assessments (e.g., FMEA, risk matrices) for quality-impacting processes, products, and systems.
• Communication: Present risk findings and mitigation strategies to senior leadership and cross-functional stakeholders.
• Action Tracking: Monitor and follow up on action items resulting from management reviews.

Change Control Management

• End-to-End Administration: Manage the full change control lifecycle: initiation, impact assessment, approval routing, and closure.
• Regulatory Compliance: Evaluate proposed changes for impact per 21 CFR Parts 210/211.
• Collaboration: Partner with Manufacturing, Regulatory Affairs, R&D, and Validation teams to implement changes effectively.
• System Optimization: Maintain and improve change control workflows within the eQMS.
• Training: Educate staff on change control procedures to ensure departmental consistency.

Quality Metrics & Monitoring

• Data Analysis: Define and report on KPIs, including CAPA cycle times, deviation rates, and audit findings.
• Reporting: Develop quality dashboards and trending reports for site leadership.
• Proactive Escalation: Identify adverse quality trends and recommend corrective actions.
• Continuous Improvement: Enhance data collection processes using tools like Excel, Power BI, or eQMS reporting modules.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or Biology (Required); Master’s degree (Preferred).
• Experience: Minimum of 5 years of QA experience in a pharmaceutical or biotech GMP environment (Required).
• Technical Expertise: Demonstrated experience managing change control, risk management, or quality metrics.
• Regulatory Knowledge: Strong working knowledge of FDA regulations (21 CFR Parts 210/211), ICH Q9, ICH Q10, and GxP.
• Systems: Hands-on experience with eQMS platforms (e.g., Veeva Vault, MasterControl, or Qualio) is preferred.
• Certifications: ASQ Certified Quality Auditor (CQA) or equivalent (Preferred).
• Skills: Proficiency in Power BI/Excel and excellent communication skills for presenting to leadership.

Benefits & Compensation

In addition to a competitive salary, Imanis Life Sciences offers a comprehensive benefits package:

• Financial Security: Simple IRA with employer match, Annual Bonus, and Life Insurance.
• Health & Wellness: Health, Dental, and Vision insurance.
• Disability Coverage: Employer-paid Short-Term and Long-Term Disability AD&D.
• Work-Life Balance: Paid Holidays and a generous PTO policy.