Senior Manager, Global Digital & Technology System Ownership

The Senior Manager, Global Digital & Technology System Ownership is accountable for the day-to-day ownership, operational health, lifecycle execution, and compliant management of Global Patient Safety R&D externally developed platforms and validated systems within the global R&D technology portfolio.

This role translates the GRDTS system ownership model into disciplined execution across technical configuration, platform operations, lifecycle planning, release and upgrade coordination, access management, documentation, security activities, vendor delivery, budget inputs, and inspection-ready evidence.

The Senior Manager partners with R&D business process owners, Global Technology Solutions, Information Security, Quality, vendors, Finance, Procurement, project teams, and support functions to ensure assigned platforms remain compliant, secure, reliable, supportable, and aligned with scientific and business needs.

The successful candidate brings strong regulated-systems experience specifically in Safety systems, hands-on operational leadership, structured problem solving, and the ability to coordinate global stakeholders through platform changes, incidents, competing priorities, and complex technical dependencies.

Essential Functions of the job:

System Ownership Execution & Governance

• Execute the system ownership model for Global Patient Safety’s externally developed platforms, maintaining clear accountability for business purposes, technical health, compliance posture, roadmap, support model, and lifecycle status.

• Maintain system governance routines, decision logs, ownership records, operating controls, documentation standards, and cross-functional action tracking for validated and non-validated platforms.

• Serve as the primary operational escalation point for assigned platforms, coordinating issue prioritization, risk review, lifecycle recommendations, and stakeholder alignment.

Technical Configuration, Platform Implementation, Upgrades & Integrations

• Lead and coordinate technical configuration, platform implementation, upgrade readiness, integration changes, environment preparation, testing support, release execution, and post-release stabilization for assigned platforms for Global Patient Safety such as Argus, Case Intake system, Signal Detection platform, and Safety data mart and etc.

• Ensure implementation and change plans align with Enterprise IT standards, cybersecurity requirements, validation expectations, business readiness, data and integration needs, and operational support models.

• Manage dependencies, risks, communications, cutover activities, vendor deliverables, and stabilization actions for upgrades, integrations, enhancements, and platform modernization efforts.

System Life-Cycle Management & Roadmap Execution

• Manage lifecycle activities for assigned systems, including onboarding, capability expansion, roadmap maintenance, technical debt reduction, modernization, retirement, and transition planning.

• Convert business needs, platform needs, functions, features, technical constraints, and compliance requirements into executable roadmap items and prioritized delivery plans.

• Coordinate feature and functionality additions, edits, and enhancements with business owners, technical teams, Enterprise IT, vendors, and Quality stakeholders.

Operational Excellence for Validated Systems

• Own execution and monitoring of validated-system operations, including user access workflows, role governance, audit trail review, periodic review, security checks, evidence collection, and remediation tracking.

• Ensure operating activities are consistently performed, documented, inspection-ready, and aligned with GxP, computer systems validation, 21 CFR Part 11, internal SOPs, and Quality expectations.

• Identify and implement improvements to operational controls, review cadence, exception management, metrics, and issue closure practices.

System Documentation & SOP Management

• Create, maintain, and periodically refresh system ownership artifacts, configuration records, technical operating procedures, administration and user access SOPs, support playbooks, and other system documentation.

• Ensure documentation reflects current configuration, access models, integrations, lifecycle status, change history, operating procedures, support arrangements, and inspection-readiness needs.

• Coordinate SOP creation, review, approval, training impacts, evidence readiness, and audit response activities with Quality, business process owners, and system teams.

System Security, Patch, Certificate & SSO Coordination

• Coordinate system security and maintenance activities, including patch planning, vulnerability remediation, certificate renewals, single sign-on coordination, identity and access dependencies, and risk-based prioritization.

• Partner with Enterprise IT and Information Security to plan and execute security actions in alignment with corporate policies, system criticality, business continuity needs, validation requirements, and change controls.

• Maintain visibility of security risks, exceptions, remediation owners, due dates, evidence, and closure status through appropriate governance and escalation channels.

Budget Support, AOP & Vendor Management

• Develop annual operating plan inputs for assigned platforms, including license, maintenance, upgrade, support, vendor, implementation, and lifecycle investment assumptions.

• Manage vendor operational performance, service reviews, roadmap follow-up, escalations, contract and statement-of-work inputs, renewal preparation, deliverables, and action closure.

• Partner with Finance, Procurement, Legal, business owners, and vendors to track spend, commitments, renewals, service expectations, and delivery against agreed business priorities.

Incident, Issue & Platform Problem Management

• Lead operational response for platform incidents, recurring problems, integration failures, access issues, service disruptions, security events, and vendor delivery issues within assigned scope.

• Coordinate root-cause analysis, corrective and preventive actions, communications, service restoration, risk documentation, escalation, and status reporting.

• Convert recurring platform issues into sustainable remediation plans, roadmap items, support model improvements, operating control changes, or vendor actions.

Cross-Functional Collaboration & Team Leadership

• Represent assigned system ownership priorities in working sessions and governance forums with R&D functions, Enterprise IT, Information Security, Quality, Finance, Procurement, and vendors.

• Lead and coach system owners, system managers, administrators, contractors, and matrixed partners in disciplined system ownership, compliant execution, technical rigor, and reliable service delivery.

• Contribute to GRDTS portfolio transparency, prioritization, audit and inspection readiness, operational metrics, and continuous improvement of technology operating practices.

Supervisory Responsibilities:

• Collaborate with System Owners, System Managers, or other assigned GRDTS resources responsible for platform operations, lifecycle activities, documentation, and validated-system execution.

• Coordinate matrixed technical resources, vendor partners, contractors, system administrators, and project teams supporting assigned systems and platform initiatives.

Key Capabilities:

• System ownership execution: applying accountable ownership models, governance routines, lifecycle controls, operating standards, and escalation pathways for R&D platforms and validated systems.

• Platform delivery and operations: coordinating configuration, implementation, integrations, upgrades, releases, roadmap items, technical debt actions, and operational stabilization.

• Regulated systems management: executing user access workflows, audit trail review, periodic review, SOP alignment, evidence management, remediation tracking, and inspection readiness.

• Security and resilience coordination: managing patch, certificate, SSO, vulnerability, incident, continuity, and risk activities with Enterprise IT, Information Security, Quality, and vendors.

• Vendor and financial stewardship: preparing budget inputs, monitoring spend, managing service performance, supporting renewals, and tracking vendor commitments to closure.

Key Competencies:

• Systems thinking across business processes, platform configuration, integrations, data flows, access controls, compliance requirements, and operational support models.

• Cross-functional influence and clear communication with R&D, Enterprise IT, Information Security, Quality, Finance, Procurement, Legal, vendors, and global stakeholders.

• Operational rigor, inspection-ready execution, sound judgment, structured problem solving, and the ability to convert ambiguous issues into clear actions and decisions.

• Composed incident leadership during outages, upgrades, integration disruptions, security issues, and vendor escalations.

• People leadership, coaching, prioritization, delegation, and accountability across direct, matrixed, contractor, and vendor resources.

Key Deliverables:

• Assigned-system ownership package covering accountability, governance cadence, lifecycle status, operating controls, documentation, metrics, risks, decisions, and escalations.

• System roadmap and execution plan covering business needs, functions, features, integrations, dependencies, lifecycle milestones, enhancement priorities, technical debt, and risk actions.

• Validated-system operations package covering access workflows, audit trail review, periodic review, evidence standards, SOP alignment, remediation tracking, and inspection readiness.

• System security and maintenance tracker covering patches, certificate renewals, SSO coordination, vulnerability remediation, security exceptions, owners, due dates, evidence, and closure.

• Budget and vendor management materials covering annual operating plan inputs, renewals, service reviews, vendor commitments, contract and statement-of-work inputs, escalation logs, and performance follow-up.

• Incident and problem management records, including root-cause summaries, corrective and preventive action plans, stakeholder updates, decision logs, and durable remediation actions.

Other Qualifications:

• 7+ years of professional experience in digital, technology, information systems, R&D technology, application operations, systems engineering, or related areas; pharmaceutical, biotechnology, medical device, or regulated healthcare experience strongly preferred.

• 4+ years of progressive leadership or management experience coordinating technical teams, matrixed partners, vendor resources, and cross-functional delivery across global or complex operating environments.

• Demonstrated experience owning or managing business-critical platforms, including configuration, implementation, integrations, release and upgrade planning, access workflows, documentation, operational controls, incident management, and production support.

• Strong working knowledge and hands on experience in managing safety case processing platform, case intake system, signal detection system, safety data marts and reports.

• Strong working knowledge of GxP, 21 CFR Part 11, computer systems validation, change control, audit trail review, periodic review, SOP governance, inspection readiness, and regulated system operations.

• Demonstrated ability to partner with Enterprise IT, Information Security, Quality, Finance, Procurement, Legal, vendors, business process owners, and global R&D stakeholders.

• Experience with single sign-on, identity and access management, patching, certificates, vulnerability remediation, incident and problem management, vendor service management, and platform support processes.

• Strong written and verbal communication skills, including the ability to explain technical risk, operational health, roadmap tradeoffs, incident status, and investment needs to senior stakeholders.

• Proficient in project, product, and operational delivery methods such as Agile, Scrum, Kanban, Lean, ITIL, or similar approaches.

Travel:

• Some travel expected as part of assigned duties

Education Required:

• Bachelor or above