Metric Bio are partnered with world-leading CDMO, on the search for a Global Head of their Quality Operations.

Role Overview

In this role you will develop and oversee global quality strategies, ensuring compliance with regulatory requirements, internal standards, and customer expectations. This role is responsible for managing quality systems, regulatory compliance, risk mitigation, and cross-functional collaboration to drive continuous improvement.

Company: World Leading CDMO - Large Molecule services.

Title: Global Head of Quality, Compliance and Operations.

Location: Hybrid - China based.

Languages: English and Mandarin

Qualifications & Experience

• Bachelor's or Master’s degree in Life Sciences, Engineering, or related field.
• Extensive experience in quality assurance/control within a regulated industry.
• Strong knowledge of international quality regulations and standards.
• Proven track record in QMS management, audits, and regulatory inspections.
• Leadership experience managing cross-site teams (100+ employees).
• Excellent communication and stakeholder management skills.
• Certification in quality management (e.g., CQA) preferred.
• Advanced problem-solving and technical investigation skills.
• Willingness to travel as needed.

Key Responsibilities - Leadership & Quality Standards

• Develop and implement global quality strategies, ensuring alignment with international regulations and industry best practices.
• Establish and maintain global quality standards, including SOPs and quality manuals.
• Oversee the Quality Management System (QMS), ensuring effectiveness and regulatory compliance.
• Manage audits, CAPA, document control, and continuous improvement initiatives.
• Ensure compliance with international and local regulatory requirements, liaising with authorities and preparing for inspections.
• Provide training and guidance on quality standards and compliance across the organization.
• Identify and mitigate quality-related risks through proactive strategies.
• Analyze quality data to drive improvements and optimize quality performance.
• Ensure customer requirements are met, using feedback to enhance processes.
• Work closely with R&D, manufacturing, and supply chain teams to integrate quality into all stages of product development.
• Oversee multi-site CAPA and change control processes to maintain compliance and prevent recurrence of issues.

Leadership & Team Development

• Lead and develop a global team, fostering a high-performance culture.
• Manage recruitment, training, performance evaluations, and professional development of quality personnel.
• Oversee budgeting and expenditures for quality functions.
• Represent the company in regulatory and GMP compliance matters.
• Support internal Global Quality Operations to ensure sustainable quality practices.

Fluency in English and Mandarin is required; additional languages are a plus.