Quality Assurance Manager

Schedule: Monday–Friday, 8:00 AM–5:00 PM Position Overview Seeking a senior-level Compliance Specialist to support GMP quality systems, regulatory compliance, audits, inspection readiness, CAPA, investigations, and quality documentation within a pharmaceutical environment. This is an independent role requiring strong judgment, problem-solving, and cross-functional communication. Management experience is not required. Key Responsibilities Lead/support GMP quality system compliance, internal/external audits, and inspection readiness . Manage CAPA, investigations, compliance issues, and corrective action plans . Review and approve quality documentation and manage Quality Technical Agreements (QTAs) . Monitor site compliance metrics and support Quality Council/Management Review activities. Conduct regulatory reviews, gap assessments, and knowledge management activities. Support supplier/vendor qualification and compliance programs. Develop/update procedures and provide technical reports and presentations to management. Collaborate with Quality, Operations, internal teams, and external partners on compliance initiatives. Required Qualifications Bachelor’s degree in a scientific/engineering discipline or equivalent experience. 5+ years of relevant GMP/quality compliance experience ; 7+ years of progressive pharmaceutical/related industry experience preferred. Strong knowledge of cGMP and pharmaceutical quality systems . Experience with internal/external audits, FDA inspections, CAPA, investigations, and documentation review . Strong technical writing, communication, analytical, and problem-solving skills . Experience with Quality Technical Agreements preferred. Familiarity with SAP/Oracle, LIMS, TrackWise, Veeva, QDocs, LMS, and MS Office is a plus. #J-18808-Ljbffr