Sr. Quality Compliance Manager

Role: Lead quality compliance strategy for GxP computerized systems within the biopharma or medical device sector, focusing on regulatory adherence and continuous improvement. Responsibilities: serve as SME for systems such as eQMS, LIMS, ERP, PLM; oversee validation, data integrity, risk management, and lifecycle compliance; lead cross-functional projects to enhance compliance and process efficiency; support audits, inspections, and metrics-driven quality initiatives. Requirements: Bachelor's in Quality, Regulatory Affairs, Engineering, or related field; 12+ years in Quality Assurance, Regulatory, or related functions in pharma/biotech/medical devices; strong knowledge of GxP systems, validation, and global regulations; experience with cross-functional collaboration. Preferred qualifications: advanced degrees or quality certifications; experience with digital quality tools and system validation best practices. High-Value: GxP computerized systems, data integrity, validation, regulatory audits, risk management, global compliance, digital quality initiatives. WorkSetup: not specified; likely office-based with potential cross-functional stakeholder engagement.