Posted:19 hours ago|
Platform:
Work from Office
Full Time
Key Responsibilities:
Product
Maintain a product backlog and product roadmap for Quality Performance management and data access.
Measure usage and maintain connections with Global Business Process owners and the
Business Excellence organization as key stakeholders defining the requirements and maintaining the data flow from source systems.
Project management
Follow and apply GSK's project management methods, tools, and practices.
Plan and manage 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.
Support and possible preparation of project investment proposals (PIPs) and necessary submission documents for capital budget approval.
Quality, risk and compliance
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.
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
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.
Visualization and automation
Strong ability to translate business requirements to usable and self-explanatory business intelligence tools in a Power BI or equivalent solution.
Business insights definition: Determine GMP needs versed non-GMP needs based on use case and requirements across multiple stakeholders and users for Enterprise Quality performance management.
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
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.
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.
Build high-quality digital capabilities by easily sharing complex information, opening up opportunities for simplified, seamless, and standardized processes.
Required knowledge/education/experience:
Bachelor’s degree with minimum of 10 to 15years of experience in pharmaceutical industry in a highly regulated environment
Project and/or program management skills, including prioritizing and delegating project team-related activities, especially within the framework of the Agile framework.
Demonstrated ability to manage validation, deployment, change management, and inspection support of large, complex, computerized systems
Experience in executing strategic business projects with the associated responsibility for risk/problem, schedule and budget management.
Ability to manage strategic supplier relationships.
Ability to lead and manage globally distributed virtual matrix teams.
Change Management Skills
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).
Resilient and self-motivated.
Ability to influence, with or without authority, at levels above and below one's class level.
Demonstrated cross-organizational communication skills in a matrix environment and demonstrated the ability to both support and challenge stakeholders and agile product development teams.
Earlier application of validation principles for computer systems by defining user requirements, design specification/definition, test cycles, and system release.
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.
Specifically: courage - the ability to question the current state of affairs and persuade to adopt future technologies
Preferred skills:
BI Automation: Power Platform (Power BI, Power App, Power Automate), MS Copilot
Programming languages preferred: SQL, Python, Mcode, DAX, Databricks
Business Process Knowledge – Operational Experience in Quality Control and Assurance
GSK India
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