Associate Director - QC Systems LES BAU Operations - GCC

Job Purpose

The Associate Director QC Systems BAU Operations GCC supports the day to day business as usual maintenance operations of QC systems such as LES.  The role manages the QC Systems LES BAU Operations team and also interacts with the wider QC System LES BAU team, site QC lab stakeholders and the Tech organization to ensure successful maintenance and use of QC systems.

The role acts as a key interface between the site QC organization and the TECH organization/software provider

Key Responsibilities

Leadership & Team Management: 

• Ensure that global processes, business rules and standards are followed for QC Systems BAU operations that are supported by the global QC Systems LES BAU Operations team.
• Focus on BAU end to end request management and Help Desk support operations, ensuring Operational Level Agreement (OLA) and Service Level Agreement (SLA) delivery timeframes are met at least 90% of the time.
• Use laboratory and system expertise and skills to identify ways to continuously improve the effectiveness and efficiency of QC Systems BAU operations to improve the user experience and improve Quality performance.  
• Ensure that compliance to data standards is maintained in order to ensure that all data configured and entered in the system is fit for all business uses.
• Proactively utilize data integrity requirements, regulatory standards, identified risks and data analytics tools and processes to manage control of laboratory data lifecycle, ensuring systems are configured and utilized to complimentarily meet regulatory requirements and productivity expectations to meet current and future needs of the QC organization. 
• Ensure risks and deviations are raised in a timely manner and act upon outcomes to identify and deliver improvements and resolve potential or actual issues. Ensure successful preparation and follow-up of inspections on QC Systems related topics. Responsible for the following periodic business activities: System audit trail review,  Annual user review
• Engage with and mentor QC systems BAU operations network to ensure effective knowledge transfer and sufficient level of capability is maintained within the QC Systems BAU operations team.

Knowledge/ Education / Experience Required

• Bachelors degree with minimum of eighteen plus (16+) years of experience in pharmaceutical industry in a highly regulated environment 
• Minimum 10 years of experience working in / with a GMP Laboratory 
• Experience in GMP laboratory testing activities
• Experience in implementation and management of IT and automated equipment.
• Experience in Data management, Data Governance and reporting / analytics.
• Ability to analyze complex data/information/scenarios and make rational, risk-based decisions which are communicated and/or escalated clearly and confidently, e.g. troubleshooting, root cause analysis, impact assessment, proposing relevant CAPAs.
• Good working knowledge of analytical equipment, techniques and laboratory operations
• Experience in managing laboratory systems data maintenance operations
• Demonstrated ability to innovate 
• Proven success in leading transformational change
• Skilled in influencing at more junior and more senior levels in the organization
• open mind and flexible approach of situation resolution and problem solving, multidisciplinary rationales, communication capacity.
• Ability to travel and work independently
• English speaker

#LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

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Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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