Job Description

Job Title: Head of Quality

Location: Japan

Company Overview: Our client is a global leading pharmaceutical company committed to delivering high-quality, innovative therapies to improve patient health and well-being. Our dedication to excellence and compliance ensures that our products meet the highest standards of safety and efficacy.

Position Overview: The Head of Quality will be responsible for overseeing all quality assurance and quality control activities within the company. This role involves strategic leadership, regulatory compliance, and continuous improvement to ensure the highest quality standards are maintained across all operations.

Key Responsibilities:

• Develop and implement quality management systems and policies to ensure compliance with local and international regulatory requirements.
• Lead and manage the quality assurance and quality control teams.
• Oversee the quality aspects of manufacturing, including the production of APIs, drug products, and finished goods.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
• Conduct regular audits and inspections to identify and address quality issues.
• Collaborate with cross-functional teams to support product development and commercialization.
• Provide guidance and training to staff on quality standards and procedures.
• Manage relationships with regulatory authorities and represent the company during inspections and audits.
• Monitor and analyze quality metrics to drive continuous improvement initiatives.
• Stay updated on industry trends and regulatory changes to ensure ongoing compliance.

Qualifications:

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in quality assurance and quality control within the pharmaceutical industry.
• In-depth knowledge of Japanese and international regulatory requirements.
• Proven track record of successful quality management in a pharmaceutical setting.
• Strong leadership and team management skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a global, cross-functional team environment.
• Proficiency in both Japanese and English.

To apply, click on the apply button or reach out to Kee Siang.

EA License No: 16S8194/R24119765

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