GSK
Manager Computer Systems QA
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Role Overview
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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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.
Collaboration and Impact
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.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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 lifecycles.
- 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.
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Preferred Qualification
If you have the following characteristics, it would be a plus:
- 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
Working model and location
This role is based in either Poland or the UK. The working model is hybrid with a mix of on-site and remote work.
#LI-GSK #LI- Remote
Skills
- Communication
- Data-Driven Decision Making
- Digital Fluency
- Influencing Without Authority
- Problem Solving
- Quality by Design
- Risk Analysis
- Stakeholder Management
Salary Range
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. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process.
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.
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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/.
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