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Position Summary

This role provides leadership as a Senior Manager of Safety Quality Management activities. As a member of the Patient Safety Japan (PSJ) Extended Leadership Team or in an equivalent role, drives organization change and development of the team and represents PSJ across the organization through strong cross-functional partnerships:

• Manage and oversee QMS (Quality Management System) in PSJ to maintain MAH in Japan.
• Coordinate and deal with GVP/GPSP inspections by HA and internal/external audits, and lead the development of CAPA as needed.
• Lead the compliance, quality and learning strategy for PSJ to meet GVP/GPSP requirements in alignment with the Global Compliance, Quality and Learning team.
• Lead process improvement initiatives that deliver efficiencies, yet maintain a high degree of quality.
• Collaborate with the team leader to guide and develop team members in line with the IPS vision.
• Foster a culture of integrity, quality, and compliance.
• Own a strategic plan to ensure excellent regulatory compliance and credibility with MHLW, PMDA, TMG, HCPs, patients and other associations.
• Lead the PSJ strategy for the management of safety/PMS-related vendors, from selection to ongoing quality oversight.

Duties/Responsibilities

• Ensure GVP and GPSP compliance, including the management and oversight of the deviation and CAPA process.
• Coordinate internally and with HA inspectors and internal auditors as a lead contact of PSJ during global PV audit of BMSKK and GVP or GPSP inspection by regulatory authorities.
• Oversees and advises on the plan for the creation and update of procedural documents, to meet internal company standards and GVP and GPSP regulations, in collaboration with Global Process Excellence team.
• Negotiate with vendors and the other pharmaceutical companies to make strategic PV/PMS agreements in collaboration with related local/global functions.
• Assist in maintaining BMSKK GVP and GPSP organizational structure documents as formal documents.
• Compile the monthly report of the Anseki and Choseki.
• Conduct self-inspection based on GVP or GPSP-SOPs and WIs.
• Lead the outsourcing strategy of GVP and GPSP operations in collaboration with stakeholders.
• Oversee the archival of local GVP and GPSP related documents stipulated in GVP/GPSP-SOP.
• Discuss effective and efficient method of safety communication with HCPs and patients at the time of EPPV with a function in PSJ that plans EPPV and the commercialization team that implements EPPV.
• Oversee the PSJ contributions to the Precautions section of the Japan package insert.
• In coordination with Global Training, lead the BMSKK training strategy and oversee the plan to ensure BMSKK colleagues are trained based on GVP and GPSP-SOPs and WIs.
• Elevate capabilities across PSJ on management of deviations, root cause analysis, CAPA.
• Foster a culture of integrity, quality, and compliance.

Reporting Relationship

Report to: Associate Director, Head of Safety Quality Management

Qualifications

Degree Requirements

• University Bachelor of Science or Master of Science desirable.
• Pharmacist license desirable.

Required experience

• Five (5) years pharmaceutical industry and GVP or GPSP operational experience.

Required knowledge

• Knowledge of Pharmaceutical & Medical Device Act., Fair Competition Code (FCC), Promotion Code and related regulations, GVP/GPSP ministerial order.
• Knowledge on provision of Medical Information in Japanese industry.
• Basic knowledge on safety management for pharmaceuticals.

Key Competency Requirements

• Negotiation skill on issues with internal and external stakeholders
• Communication skills in Japanese
• English reading and writing skills
• Cross-functional collaboration skill
• Presentation skill

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: 

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