We are seeking a strategic Associate Director to lead Development and Medical QA initiatives across the Asia-Pacific region.

This is a critical leadership role that goes beyond standard compliance; you will serve as the primary quality strategist, ensuring our clinical and medical programs meet the highest international standards while driving operational efficiency and a culture of proactive quality.

Key Responsibilities:

• Strategic QA Partnership: Act as the primary quality advisor for Clinical and Medical Affairs teams, providing guidance on risk assessment and operational oversight to ensure study integrity.

• Advancing "Quality by Design": Collaborate with cross-functional teams to streamline the drug development lifecycle, embedding proactive quality principles (QbD) early into projects to anticipate and mitigate risks.

• Inspection & Audit Excellence: Lead regional inspection preparedness and act as the primary point of contact during health authority audits, ensuring seamless coordination from initial planning through to follow-up.

• Problem-Solving & Remediation: Manage formal investigations into complex quality issues, taking ownership of timely escalations and ensuring the robust implementation of Corrective and Preventive Actions (CAPA).

• Regional Quality Culture: Work closely with the Head of Development and Medical QA (APAC) to cultivate a high-standard quality mindset, ensuring all regional activities remain consistent with global quality management frameworks.

What We Are Looking For (Core Competencies):

• Strategic Leadership: You are a change agent who looks beyond the immediate task to identify long-term value, process enhancements, and better operational outcomes.

• Influential Communication: You possess the ability to gain buy-in from diverse stakeholders, navigate conflicts effectively, and present a compelling business case to support your quality initiatives.

• Analytical Decision-Making: You demonstrate sound judgment in solving high-stakes problems, using a data-driven, analytical approach to reach informed conclusions.

• Regional Business Acumen: You understand how to navigate regulatory landscapes across different countries and can successfully coordinate quality processes within an international business context.

• Ethical Leadership: You lead by example, building trust across teams through servant leadership, integrity, and adherence to the highest business ethics.

How to Apply:

Interested applicants may apply by sending in your updated résumé (in MS Word format) to my email or apply directly:

Consultant: Tan Jun Jie

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