Are you passionate about driving innovation at the intersection of business and technology?

Join GSKs Regulatory Operations Function and take the lead in optimizing IT systems and business processes that support our mission to improve lives worldwide!

In this dynamic role, youll optimize the collaboration between Regulatory business groups and IT teams—both in-house and with vendors—ensuring seamless interaction and the efficient use of cutting-edge technology.

This role serves as the Business Owner (BO) to support the Global Regulatory Operations (GRO).

Key Responsibilities:

• Lead and coordinate business engagement in projects in collaboration with IT and Business Project Teams to ensure effective solution delivery and ongoing support
• Collaborate with cross-functional teams (including Quality, IT, GRO, Regulatory Platform & Innovation Team) to optimize regulatory systems, ensuring they effectively support business objectives
• Represent Regulatory Systems in cross-regulatory initiatives taking a lead role to define requirements, identify solutions, drive improvements, and ensure implementation
• Provide operational support to GRA (Global Regulatory Affairs) for Regulatory Systems
• Ownership and maintenance of the DTMS (Digital & Tech Management System) for our systems and tools
• Manage and perform the User Acceptance Testing (UAT) process within the project lifecycle to ensure high-quality system performance
• Proactively identify and mitigate risks associated with system usage and data management
• Support audits and inspections by demonstrating compliance and providing accurate documentation related to assigned activities
• Mentor junior staff within the team on processes and tools

Qualifications

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

• A Bachelor’s degree in a relevant field, such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline, is required
• Experience in managing/supporting regulatory business IT systems in a global environment
• Deep understanding of a regulated environment, GxP, and quality standards
• Manage and update DTMS documentation, Business System Owner responsibilities, and TPRM processes to ensure compliance and accuracy
• Experience in Business Analysis and Business Process Design
• Fluent communicator in English and the local language (Polish)
• Good team player, with the confidence to lead when appropriate

Preferred Qualifications & Skills

Please note that the following skills are preferred but not required. If you do not possess them, please still apply:

• Understanding of CFR Part 11, Annex 11, Data Integrity principles, GAMP 5 methodology, CSV, SDLC process
• Experience with Denodo, cloud data platforms (Azure, AWS, GCP), SQL, with a strong ability to write, optimize, and troubleshoot complex queries
• Hands-on experience with Databricks and Apache Spark for large-scale data processing
• Proficiency in Python for data engineering, automation, and scripting tasks
• Understanding of data fabric concepts and implementation experience with Denodo or similar technologies
• Software and System Experience (one or more):
• Veeva Regulatory Vault
• eArchive
• Power BI
• Smartsheet
• SharePoint

Why GSK?

At GSK we offer a wide range of additional benefits:

• Career at one of the leading global healthcare companies
• Hybrid work (2/3 days per week from the office)
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day

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.