Manager Computer Systems QA

You will lead Computer Systems Quality Assurance activities for regulated activities across GSK Research and Development. You will work with technical teams, system owners, IT, and quality colleagues to ensure computerized systems meet regulatory expectations for validation, electronic records, electronic signatures, and data integrity. We value clear communicators who bring practical judgement, collaborative mindset, and a focus on inspection readiness. This role offers visible impact, learning and leadership opportunities, and a chance to help unite science, technology and talent to get ahead of disease together.

You will partner with colleagues across quality, IT, project delivery, and business functions. You will translate regulatory expectations into clear, pragmatic actions. You will influence changes that reduce risk and increase efficiency. You will help shape processes and tools that support compliant delivery of computerized systems and protect patient and data integrity.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Lead and deliver computer system validation (CSV) and assurance activities across new projects and existing live systems, typically in a GCP environment.
• Advise on electronic records, electronic signatures, and data integrity expectations during system design, change and implementation.
• Support regulatory inspection readiness and act as a subject matter contact during inspections. Assist in supporting internal process and system audits.
• Work with IT, system owners and business stakeholders to shape practical, risk-based solutions and remediation plans. Assist in RCA and CAPA activities where required.
• Drive validation process changes and compliance improvement activities.
• Coach and mentor colleagues on CSV QA expectations, good practice, and risk management.

• University degree in life sciences, computer science, engineering, or equivalent experience.
• 5+ years experience in computer system validation from a QA or CSV role in a regulated life sciences environment.
• Expert knowledge of regulatory expectations for computerized systems, electronic records, electronic signatures and data integrity and experience applying computer system related regulations/policies/expectations to unique and often complex issues.
• Understanding of Software Development Life Cycle (SDLC) principles and system implementation life cycles.
• Experience working within a Quality Management System.
• Strong stakeholder engagement skills and ability to work in a matrix environment.
• Ability to identify potential computer compliance risks by interpreting changes in the internal and external regulatory environment and translate the impact to GSK.

• Practical knowledge of GAMP guidance and good practice for computerized systems.
• Experience with cloud-based solutions, SaaS platforms and associated compliance considerations.
• Experience supporting regulatory inspections or interacting with regulatory authorities.
• Familiarity with automated testing, test evidence strategies or test automation approaches.
• Knowledge of modern quality and compliance tools or analytics for assurance reporting.
• Prior experience coaching or leading small teams or technical assurance communities.
• Familiarity of expectations for computer system Audit trail reviews
• Understanding of AI specific challenges in CSV approach

• This role is based in either Poland or the UK.
• The working model is hybrid with a mix of on-site and remote work.

• Communication
• Data-Driven Decision Making
• Digital Fluency
• Influencing Without Authority
• Problem Solving
• Quality by Design
• Risk Analysis
• Stakeholder Management

• Polish Salary Range / Polski przedział wynagrodzenia: PLN 293,250 to PLN 488,750
  
  The annual gross base salary range for new hires in this position is listed above for each applicable location.
• annual bonus
• share based long term incentive program
• total benefits package

This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salar