Quality Assurance Senior Manager

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Job details

Company overview

The company is a foreign-affiliated pharmaceutical company.

Responsibilities

Provide strong support team management for GQP Head on day-to-day basis

Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply Chain, launch management, Regulatory affairs and Cooperate Quality compliance)

Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local regulation and the company Quality Management Systems and provide reports as required

Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review

Manage (initiate and investigate) all significant quality issues associated with Drug Products or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion

Provide support to develop/implement/maintain/improve QMS in line with local regulation and company QMS

Perform other duties as assigned such as described below, but are not limited to:

Provide support for regulatory agency inspection readiness and requests

Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs

Support business develop

Requirements

Required Qualification

• 5 years of related experience in a GMP/GQP environment
• Expert skills related to OOS/deviation investigations, Quality Agreements, and CMO management
• Ability to identify key priorities necessary for and be able to author/implement global policies and procedures
• Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals/tools
• Strong GMP/GQP experience and knowledge, QA/QC and regulatory compliance (Japan, US, EU and other regulatory requirements)
• Experience in drug product sterile pharmaceutical/biologics manufacturing and QC is an asset.
• Strong interpersonal skills, excellent written and verbal communication skills, good presentation, negotiation and influencing skills
• Team player, task oriented, manage multiple complex priorities and keen on working in a cross-cultural working environmen
• English language fluency, both written and verbal, with the ability to communicate at all levels within the organization (e.g. TOEIC score of above 730); any other language fluency a plus

Preferred Qualifications:

• Requires BS/BA (MS or above preferred) in a scientific discipline
• Certified Quality Auditor (e.g. ASQ) certification preferred
• Minimum of 7 years of experience in QA/QC of Pharmaceuticals and/or Medical Devices Operational knowledge of pharmaceutical processing and packaging operations

Salary

12 - 15 million yen

Location

Tokyo