QA Senior Specialist

At GSK, 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.

As a QA Senior Specialist, you will be responsible for leading the quality strategy for QA systems at the site level. This includes ensuring robust, effective, and compliant quality systems are in place, driving site-level QMS compliance, and implementing enhancements to quality systems and digital data. The role focuses on providing quality oversight, leading continuous improvement, and supporting site-specific quality processes.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Quality Management System Leadership:

• Ensure compliance of the site-level QMS to regulatory requirements, driving continuous improvement and simplifying compliance processes.
• Implement a standardized QMS approach tailored to the site's operations.

Strategy Deployment:

• Lead strategy deployment and performance management processes for site-specific Quality Systems and Improvements such as change control, deviation, CAPA, and GMP training.
• Develop and deploy strategies to improve quality culture and ensure QMS compliance at the site level.

Digital Innovation:

• Support digital innovation to enhance accessibility and relevance of QMS content for the site.
• Collaborate with site local process owners to deploy quality systems such as VQMS and SAP/ERP quality modules.

Risk Management:

• Identify and manage risks associated with site QA systems.
• Assess and translate site-specific user requirements to define optimal functionality for systems.

Process Improvement:

• Lead continuous improvement programs to drive operational excellence for critical quality processes at the site through the site Quality Improvement Plan (QIP).
• Analyze and interpret site-level quality system metrics to propose and implement process improvements.

Compliance and Governance:

• Ensure alignment, compliance, and effectiveness of site-level processes within the QMS framework.
• Support site inspections and issue resolution, ensuring alignment with local regulations.

Stakeholder Engagement:

• Build strong partnerships across site functions (e.g., QC, DDA, Engineering, and Operations) to identify, escalate, and mitigate compliance risks.
• Engage with site stakeholders to prioritize support and risk mitigation.

Basic Qualifications:

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

• Bachelor's degree
• Minimum 5 years' experience in regulated environments.
• Experience within quality.
• Experience within digital or automation projects.

Preferred Qualifications:

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

• Masters Degree.
• Strong interpersonal and leadership skills to engage, empower, and influence teams.
• In-depth knowledge of regulated quality, manufacturing, GMP/GDP requirements, and emerging regulatory trends.
• Ability to drive transformation, manage complex projects, and make independent decisions under pressure.
• Expertise in operational excellence and continuous improvement techniques.

Work Environment:
This role is **on-site** in King of Prussia, PA.

Join us in ensuring the highest standards of quality and compliance, making a difference in the lives of patients worldwide.

#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.

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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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