Job description
Site Name: UK – London – New Oxford Street, Poznan Business Garden, Poznan Grunwaldzka, Poznan Pastelowa, Stevenage, Warsaw
Posted Date: Mar 14 2025
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Business System Owner
We are seeking an experienced Business System Owner (BSO) to join our Integrated Systems Support (ISS) department within Global Clinical Operations. Our goal is to ensure our systems operate flawlessly, are validated, compliant, and fit-for-purpose. We have a relentless focus on the patient, and we challenge ourselves to innovate to accelerate the delivery of our clinical trials.
BSOs are critical in shaping the evolution of our systems in collaboration with key stakeholders across the company. They are ultimately accountable for the validation status of our systems.
Our BSOs connect people, technology, and process. They possess a broad understanding of the clinical trial execution, business processes, the software development lifecycle, and computer system validation regulations.
If this sounds like you, this is a great opportunity to enhance your skills in strategic focus, compliance, data quality, vendor and stakeholder management.
Job Purpose
* Strategic Focus:
o Lead development of strategy and roadmap to develop, release and maintain compliant and user-friendly systems for partner functions to efficiently execute business processes.
o Collaborate with business leaders, stakeholders, SMEs, and user groups to develop business requirements and insights, and to assess the impact of system changes.
o Drive system development and data quality strategy & oversee execution.
* Computer System Compliance:
o Represent system in internal audits & external inspections and ensure timely completion of corrective actions (CAPAs).
o Ensure compliance with industry regulations and GSK requirements, including proper validation and documentation.
o Manage system lifecycle including risk management and mitigation.
* Vendor Management:
o Develop strategic partnerships with internal and external stakeholders.
o Maintain vendor oversight and ensure vendors comply with GxP standards.
* Operational Oversight:
o Monitor and resolve system issues, communicate proactively with users, and escalate significant concerns as needed.
o Ensure day-to-day system operations, governance, and risk management.
o Maintain process maps, user documentation, training, and communications.
* Customer Support:
o Oversee support service and help desk operations ensuring efficient system access and effective issue resolution.
o Monitor incident tickets and set service level goals.
* Data Quality:
o Classify and control data quality according to GSK policies.
o Establish metrics demonstrating data quality.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Significant experience of validating systems to regulatory requirements (GCP, FDA 21 CRF Part 11 etc)
* Experience of managing/owning global systems with different levels of complexity
* Extensive track record of influencing and/or collaborating with software vendors, business and tech delivery partners.
* Substantial experience of identifying and delivering impactful technical and process improvements.
* Experience of representing sponsor company in regulatory inspections.
* Strong communication skills across geographies and functions.
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
* Bachelor’s degree in Computer Science, Statistics, Life Sciences.
* Project Management experience.
* Change Management experience.
Closing Date for Applications – 30th March 2025
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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