Quality Technical and Validation Manager at GSK

Marietta, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

23 May, 26

Salary

0.0

Posted On

22 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GxP Compliance, Validation, Qualification, New Product Introduction (NPI), Technology Transfer, Change Management, Process Validation, Equipment Validation, Computer System Validation (CSV), Regulatory Inspections, Analytical Technology, Method Development, Quality Assurance, Lifecycle Management, Leadership, SME

Industry

Pharmaceutical Manufacturing

Description

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; 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. 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 GSK's 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 GSK's 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: 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 (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., Master’s, 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 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com 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 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/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Responsibilities

This role is responsible for leading a team ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within manufacturing and analytical environments. Key duties include overseeing New Product Introductions (NPI), managing change control for validation lifecycle activities, and serving as a Subject Matter Expert (SME) during regulatory inspections.