What are the responsibilities and job description for the Senior Quality Associate- Risk Management position at Bridgeway Partners, Inc.?
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
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.
