Clinical Compliance and Improvement Manager

GSK•Philadelphia, PA

5d•Hybrid

About The Position

You will drive clinical compliance and continuous improvement for assigned Development Operations teams in the United States. You will work closely with clinical colleagues, quality partners, and global teams to 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 is a hybrid role based at our Upper Providence site in Collegeville, PA requiring 2-3 days on-site per week average. Some travel may be required. 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 local 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. Coach clinical teams to embed sustainable quality practices and improve ways of working. Lead and contribute to continuous improvement activities and cross-functional projects that simplify processes and raise operational standards.

Requirements

Bachelor's degree in life sciences, clinical research, medicine, pharmacy, or equivalent experience.
3 plus years of clinical operations experience supporting study delivery.
Experience with ICH Good Clinical Practice (GCP) and applicable regulatory requirements.
Experience in Global Monitoring and Site Engagement.
Experience with compliance monitoring, audits, or inspection preparation in clinical settings.
Experience leading investigations and drive corrective and preventive actions to closure.

Nice To Haves

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 working in global or matrixed organizations and with external vendors or CROs.
Familiarity with clinical systems and data visualization tools such as Veeva, Excel, or Power BI.
Strong written and verbal communication skills for clear reporting and stakeholder engagement.

Responsibilities

Build strong working relationships with assigned 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 the assigned 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 targeted reviews, self-assessments, and 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.
Mentor or coach other team members or new hires as needed.