Senior Manager, Global Digital & Technology System Ownership

This is a fully remote position, open to applicants in United States.

📋 Description

• Implement the system ownership framework for Global Patient Safety’s externally developed platforms.

• Oversee system governance practices, decision logs, ownership documentation, operational controls, standards for documentation, and action tracking across functions.

• Act as the main operational escalation point for designated platforms.

• Direct technical setup, platform deployment, readiness for upgrades, integration modifications, environment preparation, support for testing, execution of releases, and stabilization after releases.

• Handle dependencies, risks, communications, cutover tasks, vendor deliverables, and actions for stabilization.

• Oversee system lifecycle processes including onboarding, expansion of capabilities, maintenance of the roadmap, reduction of technical debt, modernization, retirement, and planning for transitions.

• Transform business, platform, technical, and compliance requirements into roadmap tasks and prioritized delivery schedules.

• Manage validated-system operations, including user access workflows, governance of roles, review of audit trails, periodic evaluations, security checks, evidence collection, and tracking of remediation efforts.

• Develop and keep up-to-date ownership artifacts for the system, configuration records, technical operating procedures, access standard operating procedures (SOPs), support playbooks, and additional documentation.

• Facilitate the creation, review, approval, training impacts, evidence readiness, and audit response activities pertaining to SOPs.

• Organize patch planning, remediation of vulnerabilities, renewal of certificates, management of single sign-on, dependencies for identity and access, and prioritization of security tasks.

• Generate inputs for the annual operating plan and oversee vendor performance, service assessments, renewals, deliverables, and contract contributions.

• Lead operational responses for incidents, recurring issues, integration failures, access challenges, service interruptions, security incidents, and problems with vendor delivery.

• Coordinate root-cause analyses, corrective and preventive actions, communications, restoration of services, documentation of risks, escalation processes, and reporting of status.

• Advocate for system ownership priorities in governance meetings with R&D, Enterprise IT, Information Security, Quality, Finance, Procurement, and vendors.

• Mentor and guide system owners, administrators, contractors, and cross-functional partners.

• Enhance portfolio transparency, prioritization, readiness for audits and inspections, operational metrics, and continuous improvement initiatives.

⛳️ Requirements

• A minimum of 7 years of professional experience in digital technologies, information systems, R&D technology, application operations, systems engineering, or related fields.

• Experience in the pharmaceutical, biotechnology, medical device, or regulated healthcare sectors is strongly preferred.

• At least 4 years of progressive leadership or management experience coordinating technical teams, cross-functional partners, vendor resources, and delivery in global or complex operational settings.

• Proven experience in 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 practical knowledge and experience managing safety case processing platforms, case intake systems, signal detection systems, safety data marts, and reports.

• Comprehensive understanding of GxP, 21 CFR Part 11, computer systems validation, change control, review of audit trails, periodic evaluations, SOP governance, inspection readiness, and operations in regulated systems.

• Ability to collaborate effectively with Enterprise IT, Information Security, Quality, Finance, Procurement, Legal, vendors, business process owners, and global R&D stakeholders.

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

• Excellent written and verbal communication skills, including the ability to articulate technical risks, operational health, roadmap trade-offs, incident status, and investment requirements to senior stakeholders.

• Familiarity with Agile, Scrum, Kanban, Lean, ITIL, or similar methodologies for project, product, and operational delivery.

• A Bachelor’s degree or higher is required.

• Some travel may be required as part of the assigned responsibilities.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Equal opportunity employer.

• Reasonable accommodation for applicants with disabilities.