System Lead (FSP)

Work Schedule

Environmental Conditions

Job Description

We are seeking a System Lead to join our FSP Team in Europe (Bulgaria Serbia Poland). This role is accountable for the end-to-end lifecycle management of Biometric GxP systems including system selection validation implementation administration operation and decommissioning.

Reporting to Biometrics Leadership the System Lead independently oversees assigned systems and related activities making risk-based decisions within established governance frameworks and escalating issues as appropriate. The role ensures that biometric systems are fit for purpose inspection-ready and fully compliant with regulatory GxP and business requirements in alignment with our company global data and systems strategy.

As the primary point of contact for system users the System Lead manages system-related inquiries issues and change impacts enabling consistent effective and compliant system use across the organization.

Main Responsibilities & Technical Competencies

1. System Strategy Selection & Procurement

Maintain expert knowledge of any standard statistical computing environments (SCE) GxP-compliant data repositories electronic data capture (EDC) platforms interactive response technologies (IRT/RTSM) analytics solutions and data standards compliance tools as well as emerging market solutions.

Proactively assess system capabilities and limitations to recommend optimisations replacements or new solutions aligned with business regulatory and data strategy needs.

Engage with business users and SMEs to gather analyse and document user requirements for new systems enhancements or replacements.

2. System Implementation & Transition Management

Lead or support system implementations and expansions in collaboration with IT Digital teams Quality Assurance business users and external vendors.

Oversee the migration of statistical studies within systems including coordination of timelines user readiness and transition risks.

Contribute to the planning and execution of new system implementations.

Produce and maintain system SOPs user guides training materials and process documentation in alignment with company standards.

3. System Validation & Regulatory Compliance

Ensure continuous maintenance of the validated state of all GxP-relevant systems including but not limited to including SCE GxP-compliant data repositories IRT/RTSM and analytics solutions in accordance with company SOPs and applicable regulatory requirements.

Coordinate validation activities for system implementations upgrades patches and expansions including:

o Validation planning and timeline tracking

o Development execution and review of UAT and validation documentation (Validation Plans and Summaries UAT scripts validation packages).

Work closely with IT and Quality Assurance to ensure systems remain inspection-ready and in a constant state of compliance with periodic reviews.

Monitor regulatory and industry developments impacting data integrity electronic records and validated systems.

4. System Usage Oversight & Performance Monitoring

Oversee day-to-day system usage across all supported platforms by performing periodic quality and compliance checks.

Monitor system performance metrics and key indicators (e.g. number of users connections study usage processing volumes).

Provide oversight of external service providers responsible for system hosting support and maintenance.

Regularly review the status of logged incidents bugs and enhancement requests with IT and system vendors ensuring timely resolution and appropriate prioritisation.

5. User Support Training & Access Management

Act as the primary business support contact for users of biometric systems.

Manage all user access requests (internal and external) ensuring appropriate role-based access and compliance with governance requirements.

Deliver system training sessions and maintain training records user guides and supporting documentation.

Develop update and maintain training materials and e-learning content to support system adoption and correct use.

Collect user feedback on system usability and training effectiveness and coordinate updates as required.

6. System Governance & Stakeholder Engagement

Serve as the primary point of contact for system governance with IT Digital Quality Assurance teams and system vendors.

Evaluate the business impact of system releases upgrades and configuration changes and provide clear recommendations to system owners regarding implementation.

Act as an active member of the Change Advisory Board (CAB) contributing to prioritisation decisions for enhancements and defect resolution.

Organise and facilitate ad-hoc governance meetings with system owners and key business stakeholders to review and validate proposed changes.

Communicate system strategy roadmap and planned changes to users and stakeholders.

Participate in user group meetings and cross-functional forums.

7. Continuous Improvement & Process Optimisation

Monitor user requests support tickets and usage patterns to identify trends recurring issues or training gaps.

Propose targeted training initiatives process improvements or system enhancements to address recurring needs.

8. System Decommissioning & Legacy Management

Support the planned decommissioning of systems including coordination of data retention archiving access and regulatory documentation in line with SOPs.

Ensure decommissioning activities are planned documented and executed in a compliant and controlled manner.

Collaborate with IT and Quality Assurance to ensure continuity of data integrity and audit readiness throughout system retirement activities.

Knowledge & Experience (preferred):

Experience working in a matrix organisation managing priorities across functions geographies and governance structures.

Exposure to global system deployments and support of multi-study or multi-region system usage.

Experience contributing to continuous improvement initiatives related to systems processes or user enablement.

Skills & Capabilities

Ability to build effective working relationships with a wide range of stakeholders including business users IT Quality and vendors.

Strong verbal and written communication skills with the ability to explain complex system or regulatory topics clearly and effectively.

High attention to detail with a demonstrated ability to produce accurate high-quality work within agreed timelines.

A collaborative mindset and genuine desire to support and enable others through reliable systems and clear guidance.

Education / Certifications (essential):

Bachelors degree in Life Sciences Information Technology Data Sciences or a related discipline providing a solid foundation in regulated environments and data-driven systems.

Language(s) (essential):

Fluent English (written and spoken).