Senior Quality Associate- Risk Management
2 weeks ago
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.
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