Senior Quality Associate – Biotech/Pharmaceutical Risk Management Focus

Are you ready to make a real impact in the world of biotechnology and pharmaceutical manufacturing? We are seeking an experienced Senior Quality Associate with a strong background in Risk Management to join our team in the Midwest . This role is key to ensuring the highest standards of product quality and regulatory compliance, with a focus on ICH Q9 and other relevant guidelines.

About Us :

The company is an innovative leader in the biotech and pharmaceutical industry, committed to advancing scientific breakthroughs that improve lives globally. You’ll work alongside a dedicated team to support the development of life-saving therapies, applying cutting-edge technologies to meet today’s most complex challenges.

Key Responsibilities :

• Lead Risk Management activities, ensuring compliance with ICH Q9 and supporting product quality across the entire lifecycle.
• Collaborate with cross-functional teams including Quality Assurance (QA), Operations, and Regulatory Affairs to develop, implement, and maintain risk management processes.
• Conduct and oversee Failure Mode Effects Analysis (FMEA) , root cause analysis, and other risk assessment tools to mitigate quality risks in manufacturing and development processes.
• Provide real-time oversight and guidance on the manufacturing floor, ensuring that Good Manufacturing Practices (GMP) are consistently followed.
• Review and approve quality-related documentation including batch records , risk assessments, and quality investigations.
• Develop and monitor process capability metrics, utilizing statistical tools to drive continuous improvement.

Qualifications :

• Bachelor’s degree in a life sciences field (advanced degree preferred) or equivalent experience.
• Minimum of 5 years’ experience in Quality or similar roles within the biotech, pharmaceutical, or medical device industries.
• Strong expertise in ICH Q9 Risk Management , including hands-on experience with FMEA, gap analysis, and risk assessments.
• Demonstrated experience working in a GMP-regulated environment.
• Proven ability to work with and influence cross-functional teams in a dynamic, fast-paced setting.

Relocation :

This role is based in the Midwest , and relocation assistance is available. We’re seeking a dynamic individual eager to take on a key role and willing to relocate for 2-3 years to the Midwest.