Investigator / Empower Business Analyst, Business Systems Owner

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Job description

• Business project lead responsible for management of interactions with R&D IT in the development and implementation of information systems; includes budgeting, resource management and adherence to timelines
• Work closely with scientific staff to understand their business processes
• Identify and recommend business process improvement opportunities to enhance end-user experience
• Delivery of upgrades and enhancements to the Empower CDS application over lifecycle of system ensuring all technology designs and solutions meet the needs of the end users
• Lead validation activities for Empower CDS in accordance with GMPs, 21CFR Part11 and MHRA and ensure compliance over lifecycle of system
• Manage communications between subject matter experts and scientific staff to ensure issues and training are addressed including knowledge sharing to solve any problems
• Coordinate downtimes for project related upgrades, updates, and configurations.
• Provide technical expertise for troubleshooting and incident resolution to user community, as well as, liaising with IT experts for problem management - including deep dives.
• Ensure documentation is completed in support of activities, quality incidents and regulatory requirements (e.g., system SOPs, change controls, validation documentation).
• Track and execute Empower CDS system periodic reviews, user account review and other computer compliance processes, as assigned.
• Responsible for fronting regulatory inspections or audit (internal and external) as well as fields questions about validation status of the Empower CDS system during a regulatory inspection or audit.
• Maintain an overall knowledge of PD functions and processes to ensure effective change management for Empower CDS and other responsible IT systems.
• To know and understand the scope of all company and local safety procedures and be able to determine their relevance to own work.
• Responsible for staying current with other competing /comparable CDS systems available in the industry.

Why you?

Basic Qualifications:

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

• BS Degree in scientific discipline or computer sciences or significant equivalent work experience.
• 3 years experience with Empower
• Experience in understanding and complying with PD processes and relevant regulations (e.g.: GMP, 21 CFR Part 11, MHRA)
• Experience managing applications and deploying IT systems within a regulated environment (Computer System Lifecycle Management)
• Knowledge of critical systems supporting the laboratory environment (e.g. electronic experiment, Chromatography systems).
• Capable of planning, organizing, and prioritizing a range of technical and change-management activities

Preferred Qualifications:

Team Working - Actively involved in team activities. Works and co-operates with others, sharing information. Has an open, positive, non-competitive stance towards others in the team. Knows and understands team goals. Communication - Expresses ideas effectively, adjusting language or terminology to the needs of the recipients. Creates a good impression, commands attention and respect, shows self-confidence. Impactfully conveys ideas and rationale through oral presentations and written communications. Customer Focus - Identifies, implements, and continuously improves work processes. Emphasizes the need to deliver quality products and/or services by defining standards and evaluating processes and services against those standards. Anticipates customer needs and continually searches for ways to increase customer satisfaction. Influencing, networking and rational persuasion - Focuses on problem rather than person. Presents arguments based on factual information. Ability to weigh up information and come to a decision. Develops and uses personal relationships with a variety of line managers and key stakeholders to achieve goals. Concerns for standards - Sets high personal standards as an example. Makes sure that work meets quality standards and takes firm action on sub-standard performance. Explicitly defines the consequences of not meeting standards.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*LI-GSK

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At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

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