Quality Assurance Manager

Manager of Quality AssuranceThe Manager of Quality Assurance is a pivotal role within our SQE organization, ensuring that all pharmaceutical manufacturing, testing, and distribution processes adhere to stringent regulatory, safety, and quality standards. This position is vital in safeguarding patient safety, maintaining product efficacy, and ensuring compliance with laws such as U.S. FDA regulations and international standards. The role requires close collaboration with T&D, Engineering, Operations, and external customers and vendors to support the full lifecycle of GxP systems.ResponsibilitiesDevelop and implement quality policies, standards, and systems aligned with the organization's mission and regulatory obligations.Set measurable quality objectives and integrate quality into the plant's culture.Communicate the importance of quality to all stakeholders, including management, employees, and suppliers.Lead the QA team, including hiring, training, and performance evaluation.Oversee inspection preparations and respond to internal and external audits.Conduct investigations into deviations, non-conformances, and CAPA (Corrective and Preventive Action) processes.Monitor supplier quality and manage vendor contracts.Lead initiatives to improve process efficiency, product quality, and compliance.Maintain and update the quality management system and quality metrics reporting.Collaborate with R&D, production, supply chain, and regulatory affairs to ensure quality is embedded in all processes.QualificationsBachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific/technical discipline.10+ years of progressive experience in pharmaceutical or biotech Quality Assurance, with a preference for experience with small-molecule/API.Strong working knowledge of FDA, EMA, and other global regulatory standards.Experience in both commercial and development phases of pharmaceutical products, including clinical development, manufacturing, and post-market activities.Demonstrated experience in autonomous and collaborative team environments, with a track record of managing change in complex, fast-paced settings.Ability to prepare for and manage internal and external audits, including investigator sites, CROs, and vendors.Experience developing, implementing, and maintaining a Quality Management System (QMS) in compliance with cGMP, ICH, and other standards.Oversight of CAPA (Corrective and Preventive Action), deviation management, change control, and training systems.Experience with risk management, design control, and supplier qualification audits.Job Type & LocationThis is a Permanent position based out of Morton Grove, IL.Pay and BenefitsThe pay range for this position is $120000.00 - $140000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Health insurance, 401k, dental, vision, PTO, etc. 10% STI incentive bonus for this role.Workplace TypeThis is a fully onsite position in Morton Grove, IL.Application DeadlineThis position is anticipated to close on Sep 4, 2026.