Senior Validation Standards Leader

GlaxoSmithKline; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

GSK is seeking a senior validation professional to lead validation across a U.S. manufacturing network. The role partners with engineering, manufacturing, quality, and regulatory teams to set practical validation strategies, maintain validated states, and support inspections.

You will coach validation engineers, oversee protocols and master plans, and act as the technical lead during inspections to ensure regulatory compliance and efficient validation practices.

Qualifications

• Bachelor's degree in engineering, life sciences, or a related technical discipline.
• 8+ years of pharmaceutical or biopharmaceutical validation experience.
• Experience leading or supervising technical teams.
• Experience authoring and executing validation protocols and plans.

Responsibilities

• Lead and coach validation engineers and subject matter experts to deliver validation projects and maintain validated states for equipment, utilities, cleaning and computerized systems.
• Develop and maintain Validation Master Plans, validation protocols and validation reports that reflect regulatory expectations and efficient practices.
• Act as technical lead during regulatory inspections and support preparation, responses and post-inspection remediation.
• Define validation requirements and provide practical guidance to engineering, manufacturing, quality and regulatory partners.
• Identify high-risk validation areas and implement standards, templates, metrics and continuous improvements to reduce risk.
• Support training, tools and the validation community to enable consistent, scalable validation across sites.

Skills

Leadership

Validation protocols

Regulatory inspections

Education

Bachelor's degree in engineering

Advanced degree (engineering/science)

Job description

GSK is seeking a senior validation professional to lead validation across a U.S. manufacturing network. The role partners with engineering, manufacturing, quality, and regulatory teams to set practical validation strategies, maintain validated states, and support inspections.

You will coach validation engineers, oversee protocols and master plans, and act as the technical lead during inspections to ensure regulatory compliance and efficient validation practices.