ROLE SUMMARY

The Enterprise Platforms & Security (EP&S) organization delivers the following capabilities for Pfizer. Business application platforms supporting Pfizer’s enterprise application and critical business processes. Infrastructure allowing business traffic to travel where it needs to go, internally and externally, along with the appropriate access controls. EP&S secures Pfizer's most important information assets through world class controls and protections and enables Pfizer's business results by making security an enabler and not a roadblock to achieving business results.

The Digital Risk Management (DRM) organization works with a global stakeholder community to incorporate legal, regulatory and corporate policy requirements into solutions, services and daily Digital operational activities. DRM strives to make compliance simple and to develop logical, robust and cost-effective compliant processes and services across Digital. 

The Sr. Manager Risk Management Consulting role will collaborate with Digital partners to ensure Digital services and solutions are planned, designed, deployed, operated, and supported in a manner which meets Digital general controls and regulatory requirements.

 This position is an individual contributor

ROLE RESPONSIBILITIES

This role will have the following primary responsibilities, but will often act under the support and direction of a senior Risk Management colleague:

• Provide strategic and operational Risk Management consultancy to Digital Lines as required.
• Align Risk Management strategies to the strategic direction and operational needs of the Digital lines as required
• In support of the development and delivery of Digital services and Digital supported solutions, provide risk management, compliance event management, periodic review, inspection readiness, and all other Risk Management activities as needed in accordance with the Digital Process Framework 
• Meet with respective Digital lines as required leadership as presented in the Risk Management engagement model; Attend program/project team meetings and engage with Senior Leadership in Digital, the business lines, and external partners
• Manage customer demand for Risk Management services and performance of Risk Management managed service provider for assigned Digital lines as required
• Drive the Risk Management strategies to support the business model with internal and external processes.
• Deliver risk management and compliance services to assigned Digital R&D, especially Pfizer Digital in Japan & APAC region
• Participate in routine reporting to assigned Digital lines on the state of compliance
• Liaise with Risk Management managed service provider to ensure BTQA role is being fulfilled for all assigned Digital projects.
• Review and approve Solution Development Life Cycle (SDLC- Waterfall/Agile methodology) deliverables or change management deliverables
• Support completion of Solution Profiles; Confirm/Approve Solution Profiles
• Assure compliance requirements are met and approve deviations, where applicable
• Assure audit/inspection awareness and preparedness
• Support audits and inspections of Digital (prior, during, and post); Work with Digital customers on the remediation of audit/inspection commitments and tracking of remediation status
• Support the monitoring of Digital process execution to identify targeted continuous improvement efforts to improve operational process effectiveness and control execution
• Assist with defined compliance strategic projects/initiatives, and manage the associated records and activity tracking
• Support multiple compliance related projects and initiatives simultaneously.

BASIC QUALIFICATIONS

• BS required; Information Security, Information Technology, Computer Science, Engineering or related majors preferred
• Native equivalent Japanese Language skill, understanding at the level of local laws, regulations and guidelines (reading, writing, speaking)
• Deep understanding of Japan customs & culture with focus on interaction with local regulators and authorities
• Updated knowledge of Japanese regulations, i.e. jGxP (GCP, GPSP, GVP, GMP...), Personal Information Protection (Healthcare Information, etc.), AI related implications, etc.
• Fluent in Japanese, English and Chinese
• Minimum 10 years of experience in the pharmaceutical or biothech industries supporting IT initiatives.
• Excellent Communication skills, capable of succinctly defining the problem and delivering options for addressing potential compliance gaps
• Experience with implementing controls aligned to principles, and concepts of regulatory compliance, and of pharmaceutical regulations
• Excellent in-depth understanding and working experience with compliance guidelines and regulations such as SOX, FDA GxP regulations, and Domestic/International privacy laws (i.e. PCI DSS, MA201, Safe Harbor, etc.)
• Excellent stakeholder management skills and organizational skills
• Ability to work independently and manage multiple priorities.

PREFERRED QUALIFICATIONS

• Experience working through a highly matrixed organization to support and drive key initiatives.
• Experience with the Microsoft Office suite, basic skills managing SharePoint sites and basic understanding of Visualization and Reporting tools.
• Good understanding of Agile methodology.
• Document review role: Highly desirable.  If done by a vendor, it is required that the vendor has the same native equivalent Japanese language skill level and knowledge of Japanese regulations

REQUIRED APPTITUDES

• Quick to establish trust and respect
• Action oriented and energetic
• Resourceful and avid learner
• Easily make connections
• Effective oral, written, and interpersonal communications skills are required as well as organizational, planning, and administrative abilities and the ability to coordinate multiple complex projects simultaneously

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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