Business Introduction
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; its 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.

Are you energized by a highly specialized technical role that leverages the latest in quality analytical technology and method development If so this Quality Technical and Validation Manager role could be a great opportunity to explore.

This key member of the site quality leadership team has a responsibility and accountability of a team that ensures the highest standards of GxP compliance in the validation and qualification of processes equipment and systems within GSKs manufacturing and analytical environments. The role is both inward facing to the site and outward facing to the GSK network and as an SME to regulators during regulatory inspections. They are pivotal in overseeing new product introductions (NPI) and associated manufacturing and analytical activities ensuring seamless introduction of products from and to other supply nodes. Using robust change management practices they ensure compliance with process equipment and computer system validation lifecycle activities to ensure systems meet regulatory and quality requirements. Doing so ensures compliance with GSK and Regulatory Standards as they apply to Validation and Process Lifecycle Management.

This role will provide YOU the opportunity to lead key activities to progress YOUR career these responsibilities include some of the following

• GxP Oversight of Validation and Qualification Activities. Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes equipment and facilities.

• Determine phase specific controls and ensure their adherence for the production and laboratory value streams

• New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with GSK and regulatory standards. This includes review and approval of process and analytical tech transfer tasks and protocols.

• Develop Review and approve equipment validation protocols for all facility services utilities equipment laboratory equipment and systems including computer systems.

• Determines change control requirements including for validation and qualification activities.

• Ensure that all validation activities are current and conducted in accordance with GSKs quality standards regulatory requirements and industry best practices.

• Work with enterprise partners (R&D global MSAT/validation Product Quality Leads) in identifying evaluating and initiating strategies to rapidly developing product transfers by developing a partnership with the business areas to which they are aligned.

• Monitor and analyze validation data identifying 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.

Why you

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors 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 (Continued Process Verification Validation Master Plans etc.) and their underpinning protocols and reports.

Preferred Qualifications:

If you have the following characteristics it would be a plus:

• Advanced degree (e.g. Masters Ph.D.) in a relevant scientific or engineering discipline.

• Strong skills to identify business requirements and to provide solutions to complex issues

• Strong 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).

What we value
We create a welcoming work environment where people can do their best work. We commit to inclusion and to helping colleagues grow. We want people who work with integrity show respect and who learn and adapt. If you are ready to take ownership of meaningful projects and help us improve how we serve patients and customers we would like to hear from you.

Ready to take the next step
Apply now to join our team and help deliver projects that make a real difference.

#LI-GSK

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 were 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your inquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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 GSKs 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 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

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