Job Description

Main Responsibilities:

Will be a member of a team of Quality Assurance professionals and will manage the Quality Assurance activities of the Marketing Authorization Holder as described below:

Ensures the implementation of GQP Quality Assurance activities and ensures activities operate within established policies/procedures, global requirements, and all applicable governmental regulations.Establishes and maintains robust local procedures to support GQP operations.Manage and work closely with manufacturing sites to ensure effective and robust Quality Systems and Quality management are in place.Manage manufacturing site deviations, significant investigations and change controls as the Marketing Authorization Holder with strong collaboration with Operations and Technical functions including Global functions.Support change control activities associated with regulatory filing updates and new product filings and launches.Supports routine GMP audits of manufacturing including remediation of audit gaps.Supports the review of Annual Product Reviews of manufacturing sites.Conducts quality due diligence assessments for pre-approval of new external partners.Support compliance activities associated with Japan Pharmacopeia and other compendial updates and changes.Support compliance activities associated with new regulatory requirements and regulatory notice requirements (e.g. nitrosamine assessments, alternative tests, etc.)Support Quality activities and engage with external partners for Business Development deals including Distribution, Divestiture, Licensing, Co-Promotion, Co-Marketing deals. May act as or support the regulatory compliance liaison on the company’s behalf with the Regulatory Agencies. Supports GQP regulatory inspections for Marketing Authorization license renewal.Collaborates cross-functionally with the Office of the Marketing Supervisor General, Pharmacovigilance Department, Regulatory Affairs Department, local manufacturing sites, and global manufacturing sites to support GQP activities to ensure compliant and stable supply of products.

Qualification & Experience:

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

Must have strong knowledge of and broad experience in Quality Assurance

Must be conversant with applicable regulatory standards including pharmacopeial standards.

Strong GMP and analytical background preferred. Must have strong demonstrated communication skills in Japanese and English. Some level of contractual and financial awareness is required.

Medical device and combination product (Auto-injector and syringe product etc.) experience preferred.

Business level in both Japanese and English

Personal Qualities:

Highly motivated and engaged individual, with strong interpersonal and leadership skills. Strong strategic and continuous improvement mindset with a collaborative and problem-solving attitude.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/30/2025

*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:R329371