Quality Systems Manager

Role: Manager of Quality Systems responsible for ensuring compliance of manufacturing processes—including pharmaceuticals, biologics, cosmetics, and combination products—with regulatory standards. Objectives: support quality assurance activities to meet business and regulatory goals. Responsibilities: lead quality documentation, implement and maintain quality systems, oversee design controls, manage cross-functional audit and compliance activities, support new product introductions and design changes, and drive process improvements. Qualifications: Bachelor's in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related field; 8+ years in quality assurance or oversight roles; strong leadership in technical and cross-functional teams; deep knowledge of GMP, QMS, and regulatory standards pertinent to pharma, biologics, or devices. Preferred: experience with product and process validation, audits (FDA, EMA, Anvisa), and quality risk management. HighValue: extensive QA experience in pharma/biologics/devices, knowledge of GMP compliance, cross-functional collaboration with R&D, Manufacturing, Regulatory, and Supply Chain. WorkSetup: not specified.