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
