MSD Assoc Dir External Quality 

South Korea, Seoul 

856474601

Job Description

Assist in managing the end-to-end processes of transfers including but not limited to: Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness and Quality System Oversight Implementation.

Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.

Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.

Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.

Education Minimum Requirement and Experience:

Bachelor of Science degree (BS) in a Science, Engineering, or related area of study with seven (7) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements;

Master of Science degree (MS) in a Science, Engineering, or related area of study with five (5) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements

Required Experience and Skills

Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience.

Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.

Strong and principled interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.

Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

Works independently, receives minimal guidance.

Communicates in English both verbally and in writing.

Preferred Experience and Skills:

Direct experience with managing external partners (CMOs, Labs, etc.)

Experience in batch disposition, deviation management, change control and participating in regulatory inspections.

Current Contingent Workers apply

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