Quality Technical and Validation Manager

About the role

This Quality Technical and Validation Manager role is a key member of the site quality leadership team, responsible for ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK’s manufacturing and analytical environments. The role is both inward facing to the site and outward facing to the GSK network and as a subject matter expert to regulators during inspections. The position is pivotal in overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless product transitions across supply nodes. Using robust change management practices, the role ensures compliance with process, equipment, and computer system validation lifecycle activities to meet regulatory and quality requirements.

Responsibilities

• Provide GxP oversight of validation and qualification activities to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines for processes, equipment, and facilities.
• Determine phase-specific controls and ensure their adherence across production and laboratory value streams.
• Provide quality oversight and approval of technology transfer activities for new product introductions (NPI), including review and approval of process and analytical tech transfer tasks and protocols.
• Develop, review, and approve equipment validation protocols for facility services, utilities, equipment, laboratory equipment, and systems, including computer systems.
• Determine change control requirements, including those for validation and qualification activities.
• Ensure all validation activities are current and conducted in accordance with GSK’s quality standards, regulatory requirements, and industry best practices.
• Collaborate with enterprise partners (R&D, global MSAT/validation, Product Quality Leads) to identify, evaluate, and initiate strategies for rapidly developing product transfers by partnering with aligned business areas.
• Monitor and analyze validation data to identify trends and areas for improvement.
• Participate in internal and external audits and inspections, providing expertise on validation and quality assurance matters.
• Oversee laboratory business applications, methodologies, and automation to ensure they meet quality and compliance standards, including their respective Computer System Validation (CSV) requirements.

Requirements

• Bachelor’s degree in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Pharmacy, Engineering).
• 10+ years of experience in the pharmaceutical or biotechnology industry, responsible/accountable for decisions and their outcomes.
• 5+ years of leadership experience.
• Experience in developing, approving, and executing process and equipment lifecycle management programs (e.g., Continued Process Verification, Validation Master Plans), and their underpinning protocols and reports.

Preferred Qualifications

• Advanced degree (e.g., Master’s, Ph.D.) in a relevant scientific or engineering discipline.
• Strong ability to identify business requirements and provide solutions to complex issues.
• Deep knowledge of regulatory requirements (e.g., FDA, EMA, ICH) and industry standards for validation and quality assurance.
• Certification in quality assurance or validation (e.g., ASQ, ISPE).
• Experience with continuous improvement methodologies (e.g., Six Sigma, Lean).

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

Benefits

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.