Associate Director, Team Lead Integrated System Support

Job Purpose

The Associate Director, Team Lead Integrated System Support is responsible for the assignment and performance of team members and/or external workers / organizations supporting Business System Owners, or acting as Business System Owners for systems in lifecycle management ensuring that the systems supported/owned by the team lead’s team are compliant, effective and efficient.

Key Responsibilities

For systems assigned to the team lead’s team:

Reliable, Compliant & Fit-for-Purpose System Landscape:

• Ensure systems comply with relevant external and internal guidelines, regulations and policies and that adequate documentation is maintained, archived and retrievable that demonstrate that systems are reliable, compliant and fit-for-purpose.
• Ensure proper execution of Computer System Validation for new systems/system changes releasing only adequately compliant, reliable and effective systems for use.
• Ensure execution of formal downstream impact analyses for system changes avoiding inadvertent disruption to operations, compliance, or business outcomes.
• Ensure proactive identification, mitigation and documentation of business and compliance risks related to systems.
• Ensure that systems work flawlessly without data flow, operational or compliance challenges at system interfaces, are end-user centric and operate effectively and efficiently.
• Ensure user demand / data volumes are regularly reviewed and scaling for systems and system support services considered as required.
• Ensure appropriate representation in audits and inspections and timely and successful completion of CAPAs from internal quality and performance issues as well as audit and inspection findings
• Ensure de-commissioning activities are completely timely and compliantly with appropriate archiving and documentation available

End-User Support

• Ensure availability of high-quality system-related guides, FAQs, trouble-shooting steps and training materials.
• Ensure delivery of adequate onboarding support for new system users, and training and other support programs for new systems or system changes including instructor-led trainings, e-learning modules, open door sessions, train-the-trainer approaches, and others.
• Ensure proactive and end-user centric communication on system updates, new features, known issues, planned outages, and resolutions in progress.
• Ensure timely and end-user centric communication and crisis management on critical system outages or incidents during disruptions and temporary workaround.
• Ensure problems reported by users are monitored, diagnosed and addressed.

Administrative Operations

• Deliver user account and access permission management as per appropriate user privileges and training status including periodic user access reviews.
• Ensure data archiving to maintain system efficiency and compliance with data retention policies.

Leadership and Team Management

• Set direction for, lead, manage, coach and develop a team of associates enabling them to excel in their roles, live the GSK values, and grow professionally.
• Foster an environment where team members feel empowered, engaged, and are aligned with GCO Working principles.
• Identify outsourcing opportunities with appropriate third party oversight to maximize cost efficiency while ensuring service delivery excellence.
• As a member of the ISS leadership team, co-drive and co-develop the functional strategies, their execution and performance of ISS  

Key Qualifications

• 14+ years of experience in clinical operations, clinical systems management, or related areas
• Significant experience of computer system validation and quality management systems within a regulated pharmaceutical environment
• Good understanding of clinical operations processes and ICH/GCP and global regulatory guidelines for drug development and approval processes
• Strong critical thinking, problem solving, and decision-making capabilities
• Ability to operate and take decisions autonomously 
• Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders, and broadly engaging with expert communities. 
• Effective communication skills with ability to communicate and influence at different levels of the organization and third parties including senior leaders

Education:- Bachelors/Masters Degree In Related Domain.

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:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

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

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