Laboratory Systems & Validation Manager

Job Summary: A leading pharmaceutical manufacturing organization is seeking a Laboratory Systems & Validation Manager to lead technical operations supporting laboratory quality, regulatory compliance, equipment qualification, software validation, and analytical testing. This role will provide technical leadership across QC, Engineering, Quality Assurance, Manufacturing, and R&D while ensuring compliance with FDA cGMP, data integrity, and applicable regulatory requirements.

Key Responsibilities:

• Lead qualification of laboratory testing equipment and related systems.
• Oversee software validation for laboratory data systems, ensuring data integrity and compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Manage QC software system administration, including data backup and system records.
• Lead analytical method validation, verification, optimization, and transfer activities.
• Assign and oversee technical projects involving laboratory equipment, software validation, analytical methods, and product lifecycle improvements.
• Lead cross-functional teams while providing training, coaching, and mentoring.
• Champion cGMP, safety, and compliance initiatives within QC operations.
• Support out-of-specification (OOS) investigations, root-cause analysis, product impact assessments, and CAPA development.
• Provide technical expertise to resolve laboratory equipment, software, and testing issues.
• Partner with Engineering/Maintenance, Quality Assurance, Manufacturing, and R&D teams.
• Draft, revise, and review technical protocols, reports, SOPs, and laboratory documentation in accordance with cGMP and Good Documentation Practices.
• Ensure compliant oversight of the software development lifecycle for validated systems.
• Develop and maintain QC metrics, business systems, and supporting documentation.
• Address laboratory and safety issues and implement appropriate corrective actions.
• Support employee development, performance management, and team effectiveness.

Qualifications:

• Bachelor’s degree in Chemistry, Microbiology, or another relevant technical field.
• 5+ years of experience in an FDA-regulated cGMP quality control laboratory environment.
• 2+ years of team management, employee development, or project leadership experience.
• Strong understanding of laboratory equipment qualification, analytical methods, software validation, and data integrity.
• Demonstrated ability to lead technical projects and cross-functional teams.
• Strong knowledge of FDA cGMP requirements and regulatory standards.

Additional Information:

• Relocation assistance available.
• Leadership role supporting quality control operations in a regulated pharmaceutical manufacturing environment.
• Significant cross-functional interaction with Quality, Manufacturing, Engineering, and R&D.