Team Leader -Change Management And Risk Management

<div><h3>Job Description</h3><p>To lead and oversee the Quality Assurance Compliance team in ensuring that all operations comply with<b>cGMP, GDP, ISO, and regulatory requirements</b>. The QA Compliance Process lead is responsible for supervising quality system activities, managing audits and inspections, and driving continuous improvement initiatives to maintain a high standard of quality compliance across the organization.</p><h3>Quality System Oversight</h3><ul><li>Lead and manage daily QA compliance operations, ensuring adherence to company and regulatory requirements.</li><li>Oversee the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).</li><li>Supervise review and closure of deviations, CAPAs, change controls, and risk assessments.</li><li>Ensure quality system data is analyzed, trended, and reported through compliance KPIs and management reviews.</li></ul><h3>Audits and Inspections</h3><ul><li>Plan, coordinate, and lead internal audits and self-inspections according to the annual audit schedule.</li><li>Prepare the organization for regulatory inspections and customer audits; coordinate responses and follow-up on findings.</li><li>Review and approve audit reports and ensure timely and effective implementation of corrective and preventive actions (CAPAs).</li></ul><h3>Documentation and Records Management</h3><ul><li>Supervise the control, review, and approval of SOPs, quality manuals, and other controlled documents.</li><li>Ensure compliance with Good Documentation Practices (GDP) and manage document lifecycle from issuance to archival.</li></ul><p>Support departments in documentation compliance and timely updates of controlled procedures.</p><h3>Change Control Management</h3><ul><li>Lead the end-to-end Change Control lifecycle (initiation, impact assessment, approval, implementation, closure).</li><li>Ensure all changes are evaluated for GMP, regulatory, validation, and supply chain impact.</li><li>Chair or coordinate Change Control Committee (CCC) / Panel meetings.</li><li>Ensure timely closure of changes within defined KPIs (e.g., extension rate ≤ target).</li><li>Oversee classification of changes (minor / major / critical) based on risk.</li><li>Ensure alignment with regulatory submissions/variations where applicable.</li><li>Monitor effectiveness checks and post-implementation review (PIR).</li></ul><h3>Continuous Improvement and Risk Management</h3><ul><li>Implement and maintain QRM framework in line with:<ul><li>ICH Q9 (Quality Risk Management)</li><li>WHO Annex 9</li><li>EU GMP Chapter 1</li></ul></li><li>Lead risk assessments (FMEA, HACCP, risk ranking, etc.) for:<ul><li>Change controls</li><li>Deviations and CAPAs</li><li>New product introduction (NPI)</li><li>Supplier qualification</li></ul></li><li>Ensure risk-based decision making is embedded across QMS.</li><li>Maintain risk registers and risk review mechanisms.</li><li>Facilitate cross-functional risk workshops.</li></ul><h3>Team Leadership</h3><ul><li>Lead and coach the CC&QRM team.</li><li>Ensure proper training and competency development.</li><li>Promote a quality culture and risk-based mindset.</li><li>Allocate workload and ensure performance against KPIs.</li></ul><h3>Environmental, Health And Safety Responsibilities</h3><ul><li>Follow the company’s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.</li><li>Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).</li><li>Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initiatives.</li></ul><h3>Qualification/Functional Knowledge</h3><ul><li>Bachelor’s or Master’s Degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related or equivalent field</li><li>Minimum 5-10 years of experience in Quality Assurance / Compliance within the pharmaceutical or biotechnology industry, including at least 2–3 years in a supervisory or team leadership role.</li><li>Comprehensive understanding of GMP, GDP, and ISO 9001 and ISO 14001 requirements</li><li>Strong familiarity with regulatory guidelines (FDA, WHO, EU).</li><li>Experience in audits, CAPA, risk management, and QMS systems.</li><li>Excellent leadership and team management skills.</li><li>Strong communication, coordination, and decision-making abilities.</li><li>Analytical thinking and problem-solving skills.</li><li>Proficiency in MS Office and electronic QMS platforms.</li></ul><h3>Job Details</h3><p>Role Level: Not Applicable<br/>Work Type: Full-Time<br/>Country: United Arab Emirates<br/>City: Ras Al Khaimah<br/>Company Website: http://www.julphar.net<br/>Job Function: Sales<br/>Company Industry: Pharmaceutical Manufacturing<br/>Sector: Pharmaceutical Manufacturing</p></div>#J-18808-Ljbffr