Quality Technical and Validation Manager

About the role

GSK is hiring a Quality Technical and Validation Manager, a key member of its site quality leadership team. The role ensures the highest standards of GxP compliance in the validation and qualification of processes, equipment and systems in manufacturing and analytical environments, and acts as an SME to regulators during inspections. It also oversees new product introductions and related manufacturing and analytical activities.

Key responsibilities

• Ensure GMP and other regulatory guidelines are followed in validating and qualifying processes, equipment and facilities
• Determine phase-specific controls for production and laboratory value streams
• Provide quality oversight and approval of technology transfer activities, including process and analytical tech transfer protocols
• Develop, review and approve equipment validation protocols for facilities, utilities, laboratory equipment and computer systems, and determine change control requirements
• Keep validation activities current and compliant with GSK quality standards and regulatory requirements
• Work with R&D, global MSAT/validation and Product Quality Leads to develop strategies for rapid product transfers
• Analyze validation data to identify trends and areas for improvement
• Take part in internal and external audits and inspections, and oversee laboratory business applications, methodologies and automation, including CSV requirements

Required profile

• Bachelor's degree in a relevant scientific or engineering discipline (Chemistry, Biology, Pharmacy, Engineering)
• 10+ years of experience in the pharmaceutical or biotechnology industry, responsible for decisions and their outcomes
• 5+ years of leadership experience
• Experience developing, approving and executing process and equipment lifecycle management programs (continued process verification, validation master plans) and their protocols and reports
• Preferred: advanced degree, strong regulatory knowledge (FDA, EMA, ICH), QA/validation certification (ASQ, ISPE), and experience with Six Sigma or Lean

Required skills

• Data integrity and GxP regulations
• Lean management and problem solving
• Technical writing