Job Purpose:
The Senior Manager-Digital Quality Operations-GCC drives innovation through a portfolio of significant product developments or owners and/or manages the deployment of complex new quality systems across multiple locations.
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Manage a small portfolio of up to 2 projects/products with an investment in the range of 0,000 to 500,000 and support the entire team in managing smaller projects to ensure projects are delivered in appropriate quality, timeframes, deliverables and authorised budgets.
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Directly provide and support data engineering/modeling, visualization, and business understanding of complex data sets to generate products to support the entire quality organization, including manufacturing sites, LOCs, and external quality. Provide insightful tools that provide strong governance of known KPIs, predictive risk management, and emerging lead actions.
The manager is able to drive cultural and business change, including digital education, to improve the speed and adoption of digital initiatives and related outcomes across the broader network of sites, LOCs, and central functions.
This allows the team to:
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Perform tasks that no one can perform (complex real-time predictive monitoring)
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Allow employees to focus on more value-added activities (e.g., automating reporting)
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Providing the right information for decision-making (e.g. Plant Control Tower)
The task further extends to challenging and eliminating traditional operating models, such as direct information gathering and selective context, to replace standard meeting decks for governance and focus only on those areas where escalation, decision-making, and action are needed.
Key Responsibilities:
Product:
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Feature Definition: Translate customer inquiries, competitive activity, and industry trends into value drivers of new technology solutions and product requirements that can be easily understood by product teams.
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Drive execution of all processes in the product lifecycle, including business and opportunity analysis, planning, requirements and roadmap development, product launch, and hyper care.
Project management:
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Follow and apply GSKs project management methods, tools, and practices.
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Plan and manage programs and projects to test proof-of-concept, proof-of-value, and industrialization of expensive, complex, and strategic systems, using risk-based approaches to ensure systems are fit for purpose, significant risks are identified and mitigated, and key budget, value-added, and time criteria related to the program are met.
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Preparation of project investment proposals (PIPs) and necessary submission documents for capital budget approval.
Quality, risk and compliance
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Ensure that all products within the scope comply with company standards, including those associated with external regulatory and legal requirements (e.g., GxP) including validation (ITMS/AeQMS, etc.), internal security and risk management policies and practices (Smart Controls and IT/OT security requirements), and all policies and procedures associated with the QMS.
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Preparation and approval of the validation documentation or management of the process (fulfilment of the quality assurance role) in accordance with the relevant processes (e.g. quality management system).
Matrix and supplier management
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Managing relationships with external partners, clear business responsibility for technical support and external party deliverables, building strong relationships to achieve common goals based on trust and cooperation.
Data modeling and visualization
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Strong ability to translate business requirements to efficiently model data across multiple source systems into data that can be easily visualized using technical features such as SQL and Python. Deliver robust models with explainability (which datasets are in scope and which data/entities) are used.
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Data landscape definition: Determine information requirements, definitions, and structures to support the GSK Data Lake and lay the foundation for creating intelligent analytics/visualizations.
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Excellence in visualization: Identifying strategies for translating complex datasets into simplified representations, contextually and with automated interpretation/focus. Leverage the capabilities of natural language processing (NLP), machine learning, and AI to instantly highlight the most relevant information to audiences and take the necessary actions to deliver proactive quality.
Change Management and Communication
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identifying/solving/avoiding project issues; Typically, it involves ongoing interaction with management teams within IT functions, on-site and on-site quality organizations, and third-party vendors/service providers.
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Go-to-market strategy and change management: In the role of change agent, support both product teams and the company in agile approaches to solution development and adoption by building enthusiasm, momentum, and visible success stories via a well-defined go-to-market strategy that works with partners from within the company.
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Build high-quality digital capabilities by easily sharing complex information, opening up opportunities for simplified, seamless, and standardized processes.
Required knowledge/education/experience:
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Bachelor s degree with minimum of 10 to 15years of experience in pharmaceutical industry in a highly regulated environment
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Project and/or program management skills, including prioritizing and delegating project team-related activities, especially within the framework of the Agile framework.
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Demonstrated ability to manage validation, deployment, change management, and inspection support of large, complex, computerized systems
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Track record in data modeling/visualization, ability to interpret business requirements and deliver fully formulated data products.
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Experience in executing strategic business projects with the associated responsibility for risk/problem, schedule and budget management.
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Ability to manage strategic supplier relationships.
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Ability to lead and manage globally distributed virtual matrix teams.
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Change Management Skills
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Effective communication skills (both written and verbal) coupled with the ability to tailor these to a variety of audiences (including summarizing technical topics for non-technical audiences).
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Resilient and self-motivated.
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Ability to influence, with or without authority, at levels above and below ones class level.
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Demonstrated cross-organizational communication skills in a matrix environment and demonstrated the ability to both support and challenge stakeholders and agile product development teams.
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Earlier application of validation principles for computer systems by defining user requirements, design specification/definition, test cycles, and system release.
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Proven track record of innovation, continuous improvement, problem-solving, and courage, as well as the ability to translate business requirements to deliver digital solutions that add value.
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Specifically: courage - the ability to question the current state of affairs and persuade to adopt future technologies.
Preferred Skills:
Programming languages SQL, Python, Power BI, Databricks
Business Process Knowledge - Operational Experience in Quality Control and Assurance
