We are seeking a strategic Associate Director to lead 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 JieEA personnel reg. no.R1878852EA License No. 17C8502
Partnering with a international Medical Device MNC whom is a leader within their therapeutic area, our client is seeking a Regulatory Affairs & Quality Assurance Executive.
Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.
In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.
You will also support the review and approval of:Change control activitiesProduct promotional activitiesProduct registrationProduct labelingRegulatory inspections and audits
You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.
