MSD Sr Spclst Quality Systems & Compliance 

Japan, Chiyoda 

897334635

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.

Personal Qualities:

Current Contingent Workers apply

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