MSD Specialist Quality Systems & Compliance 

Japan, Chiyoda 

743481992

Job Description

• Ensure the implementation of GQP Quality Assurance activities and ensure activities operate within established policies/procedures, global requirements, and all applicable regulations.
• Establish and maintain robust local procedures to support GQP operations.
• Manage and work closely with manufacturing sites to ensure effective and robust Quality Management Systems are in place.
• Manage manufacturing site deviations, significant investigations, and change controls as the Marketing Authorization Holder via 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.
• Support routine GMP audits of manufacturing sites including gap remediation.
• Support the review of Annual Product Reviews of manufacturing sites.
• Support compliance activities associated with Japan Pharmacopeia and other compendial updates and changes.
• Support Quality and Compliance activities associated with regulatory requirements and regulatory notices.
• Conduct Quality due diligence activities for pre-approval of new external partners.
• Support Quality activities and engage with external partners for various business deals.
• Support GQP regulatory inspections for Marketing Authorization license renewal.
• Collaborates cross-functionally with stakeholders including Regulatory Affairs, Pharmacovigilance, local and global manufacturing sites to support GQP activities for compliant and stable supply of products.

Current Contingent Workers apply

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

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.