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Validation Standards Manager
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#31876
Remote / WFH
GlaxoSmithKline
Job Description
Full job description
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Position Summary
You will lead validation standards and provide technical expertise across a manufacturing network in the United States. You will partner with engineering, manufacturing, quality and regulatory colleagues to set practical validation strategies, maintain validated states, and support inspections. We value clear decision makers who coach others, use risk-based judgment, and simplify complex problems.
This role offers visible impact, leadership growth, and the chance to help unite science, technology, and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
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.
Work Location
This role is on-site at a United States manufacturing location:
553 Old Corvallis Road, Hamilton, Montana, 59840, USA . Some travel may be required for inspections, audits and cross-site collaboration.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
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.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Advanced degree in engineering, science, or a related field.
Experience in cleaning validation, process validation lifecycle, or computerized system validation.Experience in sterile manufacturing or large-scale drug substance or drug product environments.Previous participation in regulatory inspections or audit response activities.Certification or demonstrated experience in project management or risk management.Experience working within a matrix organization and coaching diverse teams.
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Position Summary
You will lead validation standards and provide technical expertise across a manufacturing network in the United States. You will partner with engineering, manufacturing, quality and regulatory colleagues to set practical validation strategies, maintain validated states, and support inspections. We value clear decision makers who coach others, use risk-based judgment, and simplify complex problems.
This role offers visible impact, leadership growth, and the chance to help unite science, technology, and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
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.
Work Location
This role is on-site at a United States manufacturing location:
553 Old Corvallis Road, Hamilton, Montana, 59840, USA . Some travel may be required for inspections, audits and cross-site collaboration.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
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.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Advanced degree in engineering, science, or a related field.
Experience in cleaning validation, process validation lifecycle, or computerized system validation.Experience in sterile manufacturing or large-scale drug substance or drug product environments.Previous participation in regulatory inspections or audit response activities.Certification or demonstrated experience in project management or risk management.Experience working within a matrix organization and coaching diverse teams.
