Senior Manager, Safety Quality Management at Bristol-Myers Squibb

Kariya-shi, Aichi, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

University Bachelor of Science or Master of Science (desirable)
Pharmacist license (desirable)

Responsibilities

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
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
Oversee and advise 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 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

Skills

QMS

GVP

GPSP

CAPA

Audits

Inspections

Regulatory Compliance

Process Improvement

PMDA

MHLW

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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