Clinical Compliance and Improvement Manager

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 peoples 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. Were 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.

Position Summary:

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 GSKs 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 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.

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.

Why You

Basic Qualifications:

We are seeking professionals with the following required skills to achieve our goals:

• Bachelors 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.

Preferred Qualifications:

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

• Masters 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.

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 were 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your inquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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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Manager