Seoul, Seoul, Korea, Republic of
3 days ago
Assoc. Dir., External Quality

Job Description

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 Substance, for general advice and instruction concerning Quality Operations, but functions independently, and provides guidance as needed to team members in the Product Quality Manager role.


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; OR

·       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 Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R328369

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