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GSK
Collegeville, Pennsylvania, United States
(on-site)
Posted
15 hours ago
GSK
Collegeville, Pennsylvania, United States
(on-site)
Job Function
Other
Global Monitoring and Site Engagement (GMASE) Global Process Owner (GPO) - Clinical Operations
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
Global Monitoring and Site Engagement (GMASE) Global Process Owner (GPO) - Clinical Operations
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
Description
Site Name: Mississauga Milverton Drive, USA - Pennsylvania - Upper ProvidencePosted Date: Dec 30 2025
Global Monitoring and Site Engagement (GMASE) Global Process Owner (GPO) - Clinical Operations
GSK's success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Find out more:
Our approach to R&D
Position Summary
The GMASE Global Process Owner (GPO) is a senior, clinical operation leader who designs, governs and continuously improves clinical operational processes across GMASE. This role combines end-to-end process architecture, change leadership, data and AI-enabled insights, inspection readiness, and cross-functional governance to deliver consistent, compliant and measurable outcomes. The GPO owns a network of processes, SOP(s) and tools, drives adoption through strong change management, and partners with country, regional and functional leaders to ensure scalable delivery and performance visibility.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Process Leadership & Governance
- Act as single process owner for Monitoring and Site Management processes, SOP(s), work instructions and templates, ensuring harmonized, scalable design across Clinical Operations, TMF, Systems and Vendor Oversight, with clear roles and responsibilities that strengthen accountability and transparency across the process network.
- Architect and maintain a governance framework that defines oversight, compliance monitoring, role clarity, KPIs and escalation pathways to improve consistency and the end-user experience.
Process Strategy, Design & Transformation
- Define and map end-to-end processes, translate strategy into implementable process models, and prioritize improvements based on impact, risk and effort.
- Lead GMASE-wide transformation initiatives (e.g., monitoring oversight, TMF workflows, study training, new platforms), leveraging established methodologies and principles (e.g. Lean/Six Sigma) and AI-enabled process intelligence to streamline workflows and identify risk patterns.
Change Management, Adoption & Capability Building
- Own change management for process rollouts: stakeholder analysis, sponsorship model, communication plans, training strategy and sustainability measures.
- Co-create learning materials, run workshops and coach global/regional/country process stewards and GMASE leaders to build local capability and create change champions.
- Drive sustained adoption through governance, metrics and targeted interventions.
Data-Driven Performance & Digital Enablement
- Define process KPIs and partner with Business Excellence (BEX) and analytics/IT to build dashboards and automated reporting. Use data to diagnose root causes, prioritise fixes and demonstrate benefit realisation. Draw insights from performance data and include them into road map.
- Champion digital and AI solutions, working with enterprise taskforces to shape automation and process modernization that support ongoing and future regulation compliance and readiness.
Compliance, Quality & Inspection Readiness
- Embed risk-based controls and oversight mechanisms into owned processes to meet regulatory and quality expectations.
- Maintain audit readiness through proactive collaboration with Quality, Regulatory, Data Management, Global Study Team, Safety and Clinical Development.
Stakeholder Leadership & Governance
- Convene cross-functional working groups and steering committees; influence senior stakeholders (VP level and above) to secure resources and drive decisions.
- Provide direction to countries, regions, FSP partners and SMEs to ensure consistent global application of processes and standards.
- Manage escalations and lead issue resolution for process failures or deviations
Organizational Leadership & Culture
- Promote GSK culture and continuous improvement mindset across GMASE functions.
- Act as a visible leader for GMASE initiatives, demonstrating collaborative, data-driven and outcome-focused behaviors.
Internal and external candidates will ideally be based in GSK hubs: Canada (Mississauga), United Kingdom (London HQ), United States (Collegeville, PA), Poland (Warsaw) and Belgium (Warve). Preference will be given to candidates located in these hubs, but candidates located near other GSK clinical operations (GMASE) sites will be considered.
Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in Scientific discipline.
- Senior leader (Director level and above) with 10+ years in clinical operations, process improvement, quality or related fields, including demonstrable experience leading cross-functional, global programs.
- Proven track record owning clinical operation process landscapes, SOP/WI governance and large-scale process transformation.
- Deep expertise in change management and capability building within matrix organizations.
- Data literate and comfortable with analytics, KPI design, dashboards and AI-enabled process intelligence.
- Strong inspection readiness experience, with a track record of supporting major regulatory inspections and delivering compliant outcomes.
- Excellent stakeholder management, influencing and facilitation skills; experience engaging senior leadership.
- Operational experience with clinical systems (e.g., Veeva, CTMS, eTMF), platforms and digital transformation initiatives preferred.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
- Advanced degree in Scientific discipline
- Desirable certifications: Change Management (Prosci), Lean/Six Sigma, clinical quality/inspection readiness or relevant digital/AI qualifications.
This role is designed for a senior leader who combines operational credibility in clinical development with strong governance, inspection readiness, data fluency and the ability to lead clinical operation change at scale.
This position is hybrid, with the flexibility to work in the local office 2-3 days per week.
We encourage you to apply if you are excited about the opportunity to make a meaningful impact, grow your career, and contribute to GSK's mission. Join us in shaping the future of healthcare!
#LI-GSK
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.
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. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Job ID: 81821314
Websitewww.gsk.com
US Headquarters: Philadelphia, PA
Size:10000+ employees
Founded: 1830
Type: Company - Public (GSK)
Industry: Biotech & Pharmaceuticals
Revenue: $10+ billion (USD) per year
Video: https://youtu.be/RBdgq5VTQmM
We are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.
We also have a significant global presence with commercial operations in more than 150 countries, a netwo...
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