Quality Systems & Data Manager
Job
1925 GlaxoSmithKline LLC
Remote
Full-Time
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Job 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. Position Summary You will lead and strengthen quality systems that support safe, compliant and reliable manufacturing and laboratory operations. You will work closely with site teams, technical experts and external partners to maintain strong processes and clear data. We value practical quality systems experience, calm decision-making and a collaborative approach. This role offers growth, visible impact on patient supply and alignment with GSK's mission of uniting 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 development, implementation and continuous improvement of site quality systems, including change control, deviations, CAPA and document management. Own site data integrity controls and support consistent, compliant use of electronic records and systems. Oversee validation and qualification activities for equipment, utilities and laboratory systems to meet regulatory expectations. Review and approve quality documentation for transfers, process changes and new product introductions. Manage quality relationships with external manufacturers and suppliers, including risk assessments and corrective actions. Coach and develop quality team members and support performance management. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals Bachelor's degree in a scientific, technical or engineering discipline. 6+ years' experience in pharmaceutical, biotech or related regulated quality operations. Hands-on experience with change control, deviation investigations, CAPA and document control. Experience supporting validation or qualification activities for equipment or computer systems. Preferred Qualification If you have the following characteristics, it would be a plus Advanced degree in a relevant field such as chemistry, biology, pharmacy, or engineering. Experience managing supplier or contract manufacturing quality relationships. Practical knowledge of electronic quality management systems and data integrity frameworks. Familiarity with regulatory expectations across the United States and other regions. Experience leading continuous improvement or quality transformation projects. Prior people leadership experience, including coaching and development. Solid understanding of Good Manufacturing Practice and regulatory compliance expectations. Strong collaboration and communication skills across technical and operational teams. Working model This role is hybrid. You will spend regular time onsite and work remotely as needed. Expect travel within the United States and occasional international travel. How to apply If you want to shape quality systems that protect patients and secure supply, please apply. Tell us how your experience will help our team improve processes and deliver high quality results. We welcome applicants from all backgrounds and encourage you to apply. 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.
- usrecruitment.
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.
- feeling welcome, valued and included.
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