Quality Assurance Manager

Quality Assurance ManagerCompany: Applied BiologicsLocation: Scottsdale, Arizona (Onsite)Department: Quality Assurance & ControlEmployment Type: Full-TimeAbout UsApplied Biologics is a leading biopharma company pioneering regenerative medicine and biologics for therapeutic applications. We are committed to innovation, compliance, and ensuring the highest standards in product quality and safety.Role OverviewWe are seeking a Quality Assurance Manager with proven leadership in biopharma or pharma to oversee laboratory operations, testing, and regulatory compliance. This is a full-time onsite role in Scottsdale, AZ, offering a competitive salary and comprehensive benefits packageKey ResponsibilitiesLead and manage the QA team, ensuring adherence to testing protocols and regulatory guidelines.Oversee release testing of raw materials, intermediates, and finished products.Implement and maintain quality systems, including SOPs, deviation management, and CAPA.Collaborate with R&D, manufacturing, and QA teams to support product development and commercial production.Ensure compliance with GMP, GLP, FDA, and EMA standards.Prepare and present QC reports to senior leadership and regulatory agencies as required.Train and mentor junior QA staff in best practices and compliance standards.QualificationsProven management experience in biopharma or pharma quality controlStrong knowledge of analytical methods, microbiological testing, and process validation.Familiarity with FDA/EMA regulations, ICH guidelines, and global quality standards.Excellent leadership, communication, and problem-solving skills.Compensation & BenefitsCompetitive salary (based on experience)401(k) planHealth insuranceDental insurance

Created: 2025-10-05