Job Title: Process Lead - Vendor Management Division: Quality Directorate - QA Compliance Department Country: UNITED ARAB EMIRATES Work Location: UAE (RAK head office) Job Type: Process Lead - Vendor Management Employment Type: Full Time Employment (Limited Contract) : Purpose: The vendor management Team Leader is expected to ensure the adherence with cGMP principles and to maintain them in an effective manner. He / She will also be responsible for any vendor qualification, approval, notifications assessment, oversight, audits and materials complaint. Vendors will cover RM/PM suppliers, CMO and service providers. Key responsibilities & Accountability: Key Responsibilities: \xe2\x80\xa2 Act as SME and program owner for new vendors\xe2\x80\x99 introduction, qualification and assessment. \xe2\x80\xa2 Act as point of contact for vendors\xe2\x80\x99 notifications for quality related issues and changes. \xe2\x80\xa2 Manage the quality oversight program for vendors and distributors; in addition to material complaints handling and close out with vendor. \xe2\x80\xa2 Act as the site point of contact for service providers\xe2\x80\x99 evaluation, assessment and qualification. \xe2\x80\xa2 Ensure that new product launches and new vendors related changes are deployed correctly and in compliance with regulatory expectation. \xe2\x80\xa2 Ensure timely manner reporting of potential violation or non-compliance issues to JMT. \xe2\x80\xa2 Prepare yearly external audit schedule for Juphar potential vendor and adheres to the schedule. \xe2\x80\xa2 Assist in planning and developing assessment strategy and logistics. \xe2\x80\xa2 Lead Vendor audits and summarize the findings and communicate to the supplier and management as needed. \xe2\x80\xa2 Evaluate corrective and preventive action (CAPA) responses to the assessment findings for adequacy, including root cause and timeliness. \xe2\x80\xa2 Ensure timely receipt of responses from all applicable vendors and CMOs. Review Approve and Maintain responses. \xe2\x80\xa2 Evaluate and enhance audit procedures to ensure compliance with cGMPs /Regulatory requirements and company policies. \xe2\x80\xa2 Issue and Review contractual agreements (e.g. Quality Assurance Agreements) for vendors, third parties, service providers and CMOs \xe2\x80\xa2 Review and approve batch record documents, investigations and change controls for CMOs. \xe2\x80\xa2 Maintain proper system related KPIs\xe2\x80\x99 and trending in a way that allow continuous improvement \xe2\x80\x8eculture. \xe2\x80\xa2 Attend, Participate and Deliver Quality Council. Qualifications: - Education \xe2\x80\xa2 Education: Bachelor degree in Science / Pharmacy / Health care related. - Experience: \xe2\x80\xa2 Experience of minimum + 10 years of vendor management and QMS is required \xe2\x80\xa2 Proven experience in vendor management to resolve quality issues. - Training: Key Competencies: \xe2\x80\xa2 In-depth knowledge of the industry\xe2\x80\x99s standards and regulations guidelines. \xe2\x80\xa2 Excellent knowledge of reporting procedures and record keeping. \xe2\x80\xa2 Business acumen partnered with a dedication to legality. \xe2\x80\xa2 Methodical and diligent with outstanding planning abilities. \xe2\x80\xa2 An analytical mind, able to \xe2\x80\x9csee\xe2\x80\x9d the complexities of procedures and regulations. \xe2\x80\xa2 Excellent communication skills. Technical Competencies: