Associate Vice President

Job Description : Assistant Vice President – Quality Assurance & Regulatory Affairs Location: Indonesia Industry: Medical Devices – Medical Gloves Reporting To: CEO Experience Required: 15+ Years Education: B.Tech/M.Sc . in Polymer Science, Chemistry, or Chemical Engineering About the Company Our client is the world’s top 3 manufacturers of medical gloves, committed to quality, compliance, and global healthcare standards. With a robust international presence and advanced manufacturing capabilities, company is looking for suitable candidate to lead Quality Assurance & Regulatory Affairs . Key Responsibilities Define and implement robust Quality Management Systems (QMS) across the manufacturing cycle — from raw material inspection to final product release. Lead the development, review, and enhancement of SOPs and Work Instructions to ensure compliance with international standards. Oversee process/product validation and qualification. Minimize rejection and rework through process control and defect resolution. Lead internal audits and gap analysis for QMS and Safety Management Systems (SMS). Manage regulatory documentation, global compliance, and customer audits. Handle product complaints, conduct RCA, and drive CAPA implementation. Drive training, team capability building, and social compliance adherence. Act as a strategic business partner while upholding the company’s core values. Ideal Candidate Profile 15+ years of experience in QA/RA roles within medical gloves or similar disposable medical devices (e.g., syringes, IV cannula, catheters). Thorough understanding of ISO 13485, GMP, FDA, CE, and other global regulatory frameworks. Proven leadership in quality systems, audits, and regulatory affairs across geographies. Strong documentation and team management skills. Experience in handling international regulatory bodies and customer compliance. Compensation & Benefits : Attractive Salary (Tax-Free) With benefits like Fully Furnished Accommodation, Company Car and other expat benefit.

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