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

Join GSK's 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, you'll 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.
Be a part of a forward-thinking team dedicated to advancing regulatory excellence and making an impact on the future of healthcare.

This role serves as the Service Manager and the Business System Owner (BSO) for Smartsheet (including Smartsheet solutions) to support the Global Regulatory Operations (GRO).

Key Responsibilities (but not limited):

• 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 Smartsheet as a platform and TPRM for Smartsheet as a vendor to ensure they meet operational needs and compliance requirements.

• Serve as the System Administrator for Smartsheet, managing licenses and making purchases as required.

• 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.

• Lead a team, including setting goals, managing workload, providing feedback, and conducting performance evaluations.

• Mentor junior staff within the team on processes and tools.

Why you?

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 (including practical experience with business system ownership, business system lifecycle management, and change management).

• Comprehensive understanding of DTMS documentation, the Business System Owner role, and Third-Party Risk Management (TPRM) processes, with ownership of creating, maintaining, and updating related documents to ensure compliance and accuracy.

• Extensive experience of working within a regulated project delivery environment.

• Experience in Business Analysis and Business Process Design.

• Experience in presenting systems/ processes/documentation during audits and/or inspections.

• Strong drive to develop leadership skills and the potential to grow into a future line management role.

• Fluent and able communicator in English and local language (Polish).

• Strong communication and influencing skills.

• Ability to self-manage the work and prioritize effectively.

• Service orientation, customer-focused.

Preferred Qualifications & Skills

Please note the following skills are not necessary, just preferred.
If you do not have them, please still apply:

• Proven ability to take an organized and methodical approach to problem solving/trouble shooting.

• Understanding of CFR Part 11, Annex 11, Data Integrity principles, GAMP 5 methodology, CSV, SDLC process.

• Smartsheet Product Certification or willingness to obtain it within a specified timeframe (e.g., six months).

• Knowledge of Smartsheet premium applications such as Control Centre, Bridge, Dynamic View etc.

• Software and System Experience (one or more):

  • Veeva Regulatory Vault

  • Power Bi

  • SharePoint

  • Parexel Insight Manager – RIM and Cognos Reporting

  • Documentum D2 – Labeling System

  • CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer)

  • Global Submit Validate – Lorenz eValidator

  • Axway eSubmission Gateway – FDA Web Trader, EMA Gateway CESP

• Professional Certifications:
  Relevant professional certifications such as Regulatory Affairs Certification (RAC); Project Management Professional (PMP);certifications in IT systems management (e.g. ITIL4).

• Proven ability to effectively interact with senior managers within the organization.

• Demonstrated ability to build, mentor, and manage high-performing teams.

• Good team worker, but with confidence to lead when appropriate.

• Service orientation with a customer-focused approach.

• Strong team player with the confidence to lead when appropriate.

What we offer:

• Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.

• Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).

• Hybrid working model ( 2/3 days per week in the office).

• Career at one of the leading global healthcare companies.

• Supportive & friendly working environment.

• Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.

#LI-GSK #LI-Hybrid

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our 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.

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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