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GSK is hiring a Validation Standards Manager

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USA - Montana - Hamilton
Posted 3 hours ago
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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.


How to apply
If this role feels like the next step for your career, please apply. Share your resume and a brief note describing a recent validation challenge you led and the outcomes. We welcome applicants from all backgrounds and value inclusion. Join us to grow your career and make a meaningful impact on health.

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

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Salary Information

Salary: $110000-150000

🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.

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