GSK

Quality Systems and Data Manager

USA - Pennsylvania - Marietta Full time

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 Systems & Data Manager role could be a great opportunity to explore.

The Quality Systems & Data Manager provides leadership and development to a team of Quality professionals critical in overseeing data integrity and governance, training compliance, Quality Management System (QMS) deployment and enhancement, as well as defining and driving the site Quality Improvement Plan. Enabling the deployment of data visualization tools and AI is a strategic responsibility for this leader.  They serve in an outward facing capacity to interface with the broad GSK Quality System network and ensure successful engagement with regulatory agencies during site inspections. The role also includes responsibility for driving the GSK Production System and Data Integrity for Quality and overseeing Quality Culture and Digital Strategy initiatives for the site. The Quality Systems & Data Manager reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT), who contributes to the overall quality objectives for the site.

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

  • Responsible for creating and driving the Quality digital strategy in collaboration with site and central functions.

  • Provide leadership and strategy for site data integrity & governance program.

  • Uses lean six sigma methodologies to advance systemic quality improvements thru the GSK production system.

  • Ensure comprehensive training compliance for all relevant personnel, maintaining up-to-date training records and facilitating necessary training programs.

  • Manages implementation of local updates to site quality digital systems and is accountable for maintaining and integrating their respective detailed business processes diagrams so that their end-to-end data flow, and overall compliance, can be understood by end users and external assessors.

  • Develop, implement, and monitor the Quality Improvement Plan, driving continuous improvement initiatives.

  • Accountable for continuously driving improvement in business processes and business systems to improve compliance and productivity over time, thru the monitoring, evaluation, improvement, and effectiveness of those processes and systems and defined frequencies.

  • Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes, including implementation and maintenance of the Quality Management System (QMS).

  • Maintains a thorough and current working knowledge of compliance requirements and policies, FDA regulatory developments and industry trends and ethical pharmaceuticals.  Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems.

  • Drives Quality and DI Culture at the site by interfacing and building partnerships with the GSK Centers of Excellence and other sites to translate data integrity processes and locally maintain standards as appropriate.

 Why you?

Basic Qualifications:

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

  • BS or BA in a Science discipline.

  • 7+ years prior experience with licensed biopharmaceutical or biological products.

  • 5+ years prior experience leading an operations or quality assurance team with decision making accountability related to the management or approval of quality systems.

Preferred Qualifications:

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

  • Experience with data visualization and AI – competent in using AI as a thought partner

  • Master’s degree in science or business discipline. 

  • Versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.

  • Implementation of global quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.

  • Strong communication and problem-solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships

  • Formal training in quality systems design or administration by a recognized industry organization such as ASQ.

  • Lean / six sigma training (green belt, black belt, master black belt certification).

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

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