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Position Summary

Reporting to the Senior Manager, Quality Responsible Person, Supply Chain & In-Market Quality Korea this role is responsible for providing Quality support to the local organization, performing product release and maintaining quality management system.

Key Responsibilities

Ensure that a Quality Management System is implemented and maintained in the local market, including:

• Acts as the local Qualified Person (Registered pharmacist, Quality Responsible Person) responsible for GDP in accordance with Market regulatory requirements

• Maintains Quality System Documentation: procedures and records

• BMS Policy/Directives/SOPs impact assessment and implementation

• GDP and Local regulations impact assessment and implementation

• Ensures implementation of Deviation & CAPA management / Change control management / Self-inspection / complaint management /GMP-GDP training management / APQRS / other general quality system management

Ensures implementation of following Quality Operations in the local market:

• Product Quality status and batch release or approval to the market

• Supplier management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status

• Customer oversight: periodic customer License verification

• Local QC testing, CoA review and local release, when applicable

• Analytical transfer coordination/approval to meet product launch, when applicable

• Handling compliance/quality events with the impacted market team

• Coordination and promptly perform any market action operation, recall, for medicinal products. Mock recalls

• Support to Supply Chain to avoid Back Orders

• Quality input on shortage situations and oversight reporting to Health Authority

• Medical samples Quality distribution oversight

• Managing local redress if required

Facilitate that BMS requirements are implemented in the Local Distribution Centre/Asia Distributors (as required) for:

• Warehousing facilities

• Secondary packaging facilities

• Transportation processes

• 3rd party laboratory

Quality Risk Management

• Coordination and preparation of Quality Risk Management

• Participate in the periodic Business Review with the DC

Inspections and Regulatory Surveillance

• Maintenance of the Wholesale Distributor License and Import license with Regulatory Agency

• Import certificates, when requested

• Support the Global Quality Audits in the market

• Preparation of HA inspection in local entity and leading HA inspection

• Anticipate the new directives (Regulatory surveillance)

List of minimum requirements

Degree/Certification/Licensure

• Must possess a Bachelor's degree in Sciences and Pharmacist License is required

Required Competencies

• Ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area

• Good verbal, written and presentation skills in English, to deal effectively with all levels of management

• Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint and SAP) and in Quality Systems

• Team oriented worker with excellent interpersonal skills

• Ability to switch priorities. Ability to conduct in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical

• Ability to collaborate and communicate directly to cross functional and cross regional teams

• Negotiating skills for interfacing with Health Authorities and market business functions

• Ability to effectively communicate ideas to others to accomplish challenging goals and objectives

Experience – Responsibility and minimum number of years

• 2-7 years of progressive experience within the quality function of the pharmaceutical health care industry or with regulatory agencies

• Knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential

• Proficient in GDPs and regulations promulgated by the FDA, EMA or equivalent Regulatory Agencies; and requirements for pharmaceutical products distribution

#LI-Hybrid

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 an inclusive culture, promoting diversity 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 a diverse 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.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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: https://careers.bms.com/california-residents/

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