Director/Senior Director of Quality Assurance Director/Senior Director of Quality Assurance Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Meet Life Sciences We are seeking a strategic and hands-on Director/Senior Director of Quality Assurance (QA) to build and lead quality systems across clinical, regulatory, and manufacturing functions. This is a key leadership role responsible for ensuring compliance with FDA, ICH, and other applicable regulations while enabling the development of novel therapies. Key Responsibilities Quality Systems Development & Oversight Establish and maintain phase-appropriate Quality Management Systems (QMS) in compliance with GCP, GMP, and GLP. Oversee document control, training systems, deviation/CAPA management, change control, and audit programs. Implement and maintain electronic systems to support quality and compliance. Clinical and Regulatory Compliance Ensure clinical trial processes meet FDA, ICH GCP, and other regulatory expectations. Support QA oversight of CROs, clinical sites, and vendors through qualification, audits, and routine monitoring. Participate in regulatory inspections and ensure inspection readiness across departments. Vendor and Manufacturing Oversight Oversee quality activities related to CMOs, analytical labs, and suppliers. Review and approve quality agreements, batch records, method validation protocols, and related documentation. Ensure product quality from early clinical supply through late-stage development. Audits and Risk Management Develop and execute internal and external audit plans. Lead or support root cause investigations and implement CAPAs. Conduct risk assessments and continuous improvement initiatives. Leadership and Strategy Serve as QA lead, advising senior management on compliance strategies and quality risk. Support cross-functional collaboration with Clinical Operations, Regulatory Affairs, and CMC. Qualifications Required Bachelors degree in life sciences, chemistry, pharmacy, or a related discipline. Minimum 10 years of QA experience in the biopharmaceutical industry. Strong working knowledge of FDA, EMA, and ICH GxP regulations. Experience supporting early- to late-stage clinical trials and vendor oversight. Prior leadership in a small biotech or startup environment. Excellent written and verbal communication skills. eireann.evans@meetlifesciences.com Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Other Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Meet Life Sciences by 2x Get notified about new Director of Quality Assurance jobs in Illinois, United States . Chicago, IL $170,000.00-$230,000.00 2 weeks ago Carol Stream, IL $119,000.00-$172,000.00 2 weeks ago Director, Industrial Food Safety & Quality Audit Chicago, IL $127,577.00-$170,102.00 1 week ago Senior Food Safety Quality Assurance Manager Downers Grove, IL $62,000.00-$66,000.00 4 weeks ago Elgin, IL $130,000.00-$160,000.00 6 days ago Harwood Heights, IL $100,000.00-$100,000.00 3 weeks ago Director, Food Safety and Quality Assurance - Buckhead Chicago North Chicago, IL $137,500.00-$261,000.00 6 days ago Associate Director, Medical Affairs Quality Assurance North Chicago, IL $137,500.00-$261,000.00 3 weeks ago Oak Brook, IL $127,000.00-$216,000.00 1 month ago Vice President of Clinical Operations (Skilled Nursing) Sr. Director, Product Management, Developer Experience - Quality Assurance Regional Director of Operations - MidWest Regional Food Service Director of Operations Associate Director, Medical Affairs Quality Assurance Joliet, IL $85,000.00-$95,000.00 1 day ago Urbana-Champaign Area $95,000.00-$100,000.00 2 weeks ago Quality Manager (Heavy Civil Construction) Des Plaines, IL $99,756.00-$149,633.00 6 days ago Regional Technical Director Chemistry - North America Chicago, IL $101,400.00-$172,500.00 1 month ago Mgr of Quality Bone Marrow Transplant - Hybrid-18918 Project Director Workforce Supports (44053) Associate Director, Volunteer Communications & Marketing Glenview, IL $120,542.72-$156,710.84 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr