Quality Systems & Data Manager

Regulatory Jobs; Zebulon (NC); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

GSK, a global biopharma leader, seeks a senior Quality Digital Program lead in the US. The role focuses on creating and driving the digital quality strategy, strengthening data integrity governance, and delivering smart manufacturing initiatives.

You will collaborate across site and central functions to ensure compliant, reliable operations. The role emphasizes leadership in digital quality, regulatory alignment, and continuous improvement, with a hybrid work model and the potential for growth

Qualifications

• Bachelor’s Degree in a Scientific, Technical, Computer Science discipline or equivalent experience.
• 8+ years’ experience in commercial pharmaceutical manufacturing facility, including supervisory roles.
• Fundamental understanding of digital systems and lean six sigma methodologies.
• Digital quality, data integrity, and data governance expertise.

Responsibilities

• Create and drive the Quality digital strategy in collaboration with site and central functions, including delivery of smart manufacturing initiatives.
• Lead the site data integrity and governance program.
• Apply lean six sigma to advance quality improvements within the production system.
• Ensure training compliance and maintain training records.
• Manage local updates to site quality digital systems (VQMS, MERP) via change management.
• Develop, implement, and monitor the Quality Improvement Plan.
• Collaborate with cross-functional teams to align quality systems and processes.
• Maintain quality documentation systems and regulatory compliance.
• Drive Quality Culture at the site.

Skills

Lean Six Sigma

Data governance

Data analytics

Digital quality

Regulatory knowledge

Education

Bachelor’s degree in science/technical field

Tools

VQMS

MERP

Job description

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.
Key Responsibilities
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, including delivery of smart manufacturing initiatives.
• Provide leadership and strategy for the site data integrity and governance program.
• Uses lean six sigma methodologies to advance systemic quality improvements through 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 including VQMS, MERP through appropriate change management procedures.
• Develop, implement, and monitor the Quality Improvement Plan, and drive continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes.
• Develop and maintain quality documentation systems, ensuring regulatory compliance, accessibility, and continuous improvement.
• Drive initiatives for Quality Culture at site.

Why You?

Basic Qualification

• Bachelor’s Degree in a Scientific, Technical, Computer Science discipline or equivalent experience
• 8+ years’ experience in commercial pharmaceutical manufacturing facility, including supervisory roles.
• Fundamental understanding of digital systems, tools to drive continuous improvement, and lean six sigma methodologies.
• Digital quality, data integrity, and data governance expertise.

Preferred Qualification

• Knowledge of electronic quality management systems, data integrity frameworks, and regulatory expectations.
• Leadership experience, strong collaboration skills, and effective decision-making capabilities.
• Proficiency in data analytics and reporting.
• Digital quality, data integrity, and data governance expertise.

Working model

This role is hybrid. You will be expected to work on-site regularly, with flexibility for remote work as agreed with your manager.

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 [e-mail]

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.

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/