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Associate Director - Quality Leader, External Site, Korea, Seoul

게시됨 2024-02-07
만료 2024-03-07
ID #2021401423
Free
Associate Director - Quality Leader, External Site, Korea, Seoul
Korea South, 서울, 서울,
게시됨 February 7, 2024

설명

Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.

Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create a codependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The External Site Quality Leader (ESQL) is accountable for providing Quality Oversight over one or more External Entities that manufactures or tests cell banks, biologic drug intermediates, biologic drug substances, or biologic drug products or both on behalf of our Company's Manufacturing Division.

Activities include the broadest possible involvement in every aspect of manufacturing and testing operations related to the quality and compliance of products produced.

Accountable for oversight of an External Entity (EE) involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.

Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight | Components may include review of batch documentation and deviation investigations.

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.

Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews | Includes building effective quality systems at the EE and continuous improvement activities.

Exhibits our company Leadership Behaviors and provides a leadership example for the team.

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.

This position reports to the Quality Operations Director, Large Molecule Drug Product, for general advice and instruction concerning Quality Operations, but functions independently, and also provides guidance as needed to team members in the Product Quality Manager role.

Education Bachelor's or master’s degree in a Science, Engineering, or related area of study with eight (8) 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 Experience and Skills Required 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 Desirable Experience: Direct experience with managing external partners (CMOs, Labs, etc.)Experience in batch disposition, deviation management, change control and participating in regulatory inspections.

Who we are … For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for … In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come.

We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

작업 세부 정보:

직업 종류: 풀 타임
계약 유형: 영구적인
급여 유형: 월간 간행물
직업: Associate director - quality leader, external site, korea

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