Business System Owner

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Act as Primary point of interaction with R&D Tech with respect to computer system management for one or more software applications
• Provide managerial guidance and operational direction for specialist staff across assigned site locations
• Contribute to and lead, where required, cross matrix teams of validation specialists, system admins & lead users for the development, validation, and support of analytical data capture applications.
• Maintain compliance with corporate quality standards (e.g. ITMS) and regulated requirements (e.g., Data Integrity, 21CFR Part11) in drafting, approval, implementing and revising of product-specific controls (Quality Plan, System Accessibility Plan, etc.) and change releases.
• Maintain GMP inspection readiness and business continuity of assigned applications providing first line support for audits and delivery of application related controlled documents and operational quality items e.g. CAPA’s and deviations.
• Provide business centric expertise for Analytical Systems and related business processes throughout the system life-cycle (Initiation, Development, Implementation, and Support).
• Collaborate with scientists, design specialists, data strategy leads and Tech product owners (POs) to ensure proper requirements gathering, solution development and change management in a SAFe Agile manner.
• Identify, manage, and mitigate risks to the business, due to Systems based issues.
• Provide regular and appropriate updates including metrics and status reports, maintain project plans on behalf of the
• business where required.
• Maintain awareness of changes in the external environment, new technologies, and their potential for utilization within CMC functions

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS/MS in Computer Science, Managed Information Systems (or business degree equivalence), Bioprocess/Biochemical/Chemical Engineering, Biology, Chemistry, Computer Science, Applied Mathematics, Physics, or Statistical Sciences with 5 years of industry experience (preferably in a CMC organization).
• Experience working with information technologies and systems and their applications in the pharmaceutical industry (e.g. Laboratory Information Management Systems, Electronic Lab Notebooks, Chromatography Data Systems, Distributed Control Systems).
• Experience as a change and/or project manager
• Experience working with quality standards and regulatory requirements (e.g., cGMPs, 21CFRPart11, Data Integrity)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Ability to effectively communicate and influence senior stakeholders, scientists, and tech colleagues
• Highly motivated self-starter, with excellent verbal and written communication skills
• Understanding of SAFe Agile development
• Knowledge and experience of scientific workflows
• Experience as an administrator and/or SME for the support and/or development of a scientific information system Programming experience in one or more languages

#LI-GSK

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

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