Senior QA Documentation Specialist

Business IntroductionWe 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 SummaryThe Senior QA Documentation Specialist is responsible for advanced oversight, governance, and continuous improvement of cGMP quality systems supporting vaccine manufacturing at the Marietta site. This role serves as a recognized subject matter expert (SME) for Documentation systems, with increased accountability for system performance, regulatory compliance, inspection readiness, and data integrity.The Senior QADocumentation Systems Specialist provides evaluates quality risks, leads complex investigations and CAPAs, provides quality decision‑making for their assigned system. The individual partners cross‑functionally to ensure quality systems are robust, effective, and aligned with global and regulatory expectations.ResponsibilitiesThis role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Acts as site-level system owner or SME for assigned cGMP quality systems, ensuring the Documentation Systems procedures/processes are robust and compliant with Regulatory and global requirements. Owns Documentation system performance, including KPI development, trend analysis, escalation, and action planning.Provides risk‑based quality assessments and recommendations to site leadership and cross‑functional stakeholders.Leads inspection readiness activities, including system defense, data package preparation, inspector interaction, and response authorship.Responsible for execution of training activities on cGMP quality systems (Qualified Trainer).Serves as QA liaison with site operations and global quality organizations to resolve systemic quality issues.Mentors and coaches site individuals, providing technical guidance and system knowledge transfer.Responsible for backup roles for Documentation Coordinator and Quality Manager when applicable. Leads quality system continuous improvement and simplification initiatives with measurable compliance or efficiency outcomes.Completes all activities in compliance with cGMPs, internal procedures, EHS requirements, and regulatory standardsWhy You?Work modelThis role is hybrid. You will be on site regularly and will have flexibility to work remotely. Occasional travel to supplier sites and audits is expected.Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:Bachelor’s degree in a scientific, engineering, pharmacy or related discipline, or equivalent experience.5+ years pharmaceutical or regulated industry experience within a Quality organization, with demonstrated ownership of quality systems.Experience supporting regulatory inspections and authoring or contributing to inspection responses.Experience with data trending, KPI development, and management review reporting.Technical understanding of industry & science practice related to business.Preferred QualificationIf you have the following characteristics, it would be a plus:Master’s degree in science or business discipline or an additional BS.Strong ability to influence cross-functional stakeholders and drive compliance without direct authorityAdvanced knowledge of cGMP regulations and quality system governanceDemonstrated application of quality risk management principlesStrong written and verbal communication, including inspection‑facing interactionsAbility to mentor others and act as an informal technical leaderProficiency with electronic quality management systems (eQMS) and data integrity controlsWhat we valueWe act with transparency, respect and integrity. We make evidence-based decisions and balance speed, rigor and risk. We welcome people from all backgrounds and support an environment of inclusion where everyone can do their best work. We value those who are curious, collaborative and committed to improving quality for patients.Ready to apply?If you are passionate about clear, compliant documentation and want to make a meaningful impact, please apply. Tell us how your skills in documentation and quality will help our team and our mission to get ahead of disease together. We look forward to hearing from you.#LI-GSK#Globalsupplychain#GSKCareers#GSKMarietta#MariettaGSCSkillsData Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical WritingPlease 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 - View email address on click.appcast.io 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/ AgenciesGSK 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 SummaryLocation: USA - Pennsylvania - MariettaType: Full time