Hiring: Deviations and Batch Records Manager Company: Lonza Location: Houston, TX Job Posted Time: 2026-09-16 14:48:05 Employment Type: On-site Target Skills & Keywords : Program Management, Project Management, Quality Assurance, Regulatory Compliance, Root Cause Analysis About the job Experience: •5+ years of experience in a cGMP-regulated pharmaceutical, biotechnology, cell therapy, gene therapy, biologics, or advanced therapies manufacturing environment. Required Skills: •Lead and oversee a team of deviation investigators and quality records professionals, ensuring accurate, compliant, and timely completion of investigations and GMP quality records. •Provide leadership, mentoring, coaching, and technical guidance to team members while supporting employee development, performance management, and succession planning. •Review and approve complex deviation investigations, root cause analyses, corrective and preventive actions (CAPAs), and quality records to support product disposition and regulatory compliance. •Partner closely with Manufacturing, Quality Assurance, Engineering, Validation, Supply Chain, and Program Management teams to facilitate timely resolution of quality events and support manufacturing operations. •Monitor departmental performance metrics, prioritize workloads based on business needs, and drive reduction of overdue investigations and quality records. •Serve as a strategic quality partner by identifying compliance risks, escalating critical quality issues, and ensuring appropriate mitigation activities are implemented. •Lead continuous improvement initiatives focused on investigation effectiveness, record closure cycle times, right-first-time performance, and inspection readiness. •Support internal audits, customer audits, and regulatory inspections through preparation of quality records, metrics, and subject matter expertise. Qualifications: •Medical, dental and vision insurance •Life insurance, as well as short-term and long-term disability insurance Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!