Business Introduction:
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
This role is hybrid. You will be expected to work regularly from our office (2-3 days on-site per week average) and collaborate with international colleagues across different time zones. Office sites: US - Upper Providence, UK - HQ, Stevenage, Belgium - Wavre, Poland - Warsaw.
Position Summary:
You will drive clinical compliance and continuous improvement within Development Operations. You will work closely with clinical colleagues, quality partners, and global teams to monitor compliance, find root causes and deliver practical improvements. You will help teams stay inspection ready while protecting patient safety and data integrity. We seek collaborative problem solvers who communicate clearly, act with integrity, and deliver measurable results. This role offers visible impact, learning across functions, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Lead/contribute to risk proportionate compliance monitoring activities and monitoring deliverables to identify quality gaps and operational risks.
Drive investigations and analysis, lead and support root cause analysis, and help define corrective and preventive actions
Partner with R&D Quality and Risk colleagues on inspection readiness and regulatory expectations.
Track trends and metrics, translate findings into clear action plans, and measure outcomes.
Lead and contribute to continuous improvement activities and cross-functional projects that simplify processes and raise operational standards.
Responsibilities:
Build strong working relationships with Development Operations teams and stakeholders.
Drive compliance with GCP, regulatory/legal requirements and GSK written standards
Ensure that issues and operational challenges are appropriately identified, managed, addressed and communicated in Development Operations team(s)
Collaborate closely with the R&D Quality & Risk Management organization to share information on potential risk areas and obtain insights into risks that require mitigation by Development Operations
Plan and execute Management Monitoring, targeted reviews, self-assessments, data-driven analysis and compliance monitoring.
Ensure timely development, implementation, and verification of corrective actions.
Produce clear reports and governance materials for leadership and quality forums.
Support audit and regulatory inspection preparation and responses as needed.
Maintain business continuity planning and support activation when required.
Why You?
Basic Qualifications:
We are seeking professionals with the following required skills to achieve our goals:
Bachelor's degree in life sciences, clinical research, medicine, pharmacy, or related.
3 plus years of clinical operations experience supporting study delivery.
Experience with ICH Good Clinical Practice (GCP) and applicable regulatory requirements.
Experience with compliance monitoring, audits, or inspection preparation in clinical settings.
Experience leading investigations and driving corrective and preventive actions to closure.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Master’s degree in a relevant scientific or clinical field.
Experience performing root cause analysis and integrating quality system approaches.
Experience supporting regulatory inspections or audit responses.
Ability to analyze operational metrics and convert them into practical improvements.
Experience in the use of Artificial Intelligence for data analytics and monitoring
Familiarity with clinical systems and data visualization tools such as Veeva, Excel, and Power BI.
Experience working in global or matrixed organizations and with external vendors or CROs.
Strong written and verbal communication skills for clear reporting and stakeholder engagement.
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 appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
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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