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.

This role serves as the Business Owner (BO) 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 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

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

• 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

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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.

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.

Important notice to Employment businesses/ Agencies

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/