Job Description

【Main Responsibilities】

Supports new product launch projects and associated Quality & Compliance activities in accordance with established company policies/procedures and applicable governmental regulations:

• Supports Regulatory GMP Compliance Inspections of foreign and domestic manufacturers for New Product Applications, Partial Change Applications, and Periodic GMP inspections, including support for remediation of any GMP gaps.  
• Participates in cross-functional new product launch projects to support Quality & Compliance activities.
• In collaboration with Manufacturers and Regulatory functions, manages the Conformance Review Process to evaluate compliance of site practices against the marketing authorizations.
• Establishes and maintains local procedures for above activities.

In addition, supports the following Quality Assurance activities of the Marketing Authorization Holder:

• Assures Quality Assurance activities operate within established policies/procedures, global requirements, and all applicable governmental regulations.
• Establishes and maintains robust local procedures to support implementation of all Quality Assurance activities as defined in the GQP regulations.
• Critically assess Quality Systems and their implementation to ensure procedures are followed appropriately. Supports the generation of and tracking of CAPAs, as part of the GQP self-inspection process.
• Drives proactive and continuous improvement of all GQP processes.
• Performs market release of products including management of the release schedule and ensures a robust release process.
• Ensures Quality Agreements are in place with all manufacturers and fully meets the intent and requirements of GQP.
• Coordinates and implements the GQP training program.
• Supports Computer System Validation activities relating to GQP systems.
• Ensures Quality Standard Codes for all company products are maintained as current.
• Supports coordination of any recall activities across a cross-functional team.

Collaborates cross-functionally with the Office of the Marketing Supervisor General, Regulatory Affairs Department, Pharmacovigilance Department, local and global manufacturing sites to perform above activities.

Qualification & Experience:

BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.

Must have strong knowledge of and experience in Quality Assurance and/or Quality Control activities. Must have strong demonstrated communication skills in Japanese and English. Must be knowledgeable of applicable regulations governing operations. Highly motivated individual, with strong interpersonal and leadership skills.

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2025

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