Plant Lead - Quality

Position Summary : Plant Lead - QualityLocation: DIC DubaiReporting: Plant HeadRole Context & PurposePlant Lead - Quality to lead Quality Assurance (QA) and Quality Control (QC) & Micro departments in pharmaceutical manufacturing facility. The ideal candidate will have a minimum of 10 years of experience in pharmaceutical manufacturing, proven expertise in SAP implementation, and a strong background in quality control, and a solid understanding of conducting and managing audits.Key Reponsibilities Quality Assurance Leadership:Develop, implement, and oversee quality assurance policies and procedures to ensure compliance with pharmaceutical regulations, industry standards, and internal quality standards.Lead and mentor the QA team, providing guidance and support to ensure effective quality management practices.Monitor key quality metrics and implement corrective and preventive actions to address any issues and drive continuous improvement. SAP Implementation and Optimization:Manage the implementation, configuration, and optimization of SAP Quality Management (QM) modules to support quality assurance processes.Collaborate with IT and SAP consultants to ensure that SAP solutions are aligned with quality management needs and regulatory requirements.Provide training and ongoing support to QA and production teams on SAP QM functionalities and best practices. Audit Management:Prepare for, conduct, and oversee internal and external audits, including regulatory inspections and certifications.Address and resolve audit findings and non-conformities, implementing corrective actions as needed.Maintain up-to-date knowledge of audit requirements and industry standards to ensure compliance. Regulatory Compliance:Ensure all QA processes are compliant with Good Manufacturing Practices (GMP), FDA, EMA, and other relevant pharmaceutical regulations.Stay current with changes in regulatory requirements and ensure that QA processes are updated accordingly.Coordinate with regulatory bodies and ensure timely and accurate submission of required documentation. Continuous Improvement:Identify and lead initiatives to improve QA processes, enhance efficiency, and ensure the highest quality standards.Implement and promote best practices and continuous improvement methodologies within the QA department.Analyze quality data and trends to drive decision-making and process enhancements. Documentation and Reporting:Oversee the creation, maintenance, and review of quality documentation, including Standard Operating Procedures (SOPs), validation protocols, and quality reports.Ensure accurate and timely reporting of quality metrics and performance to senior management. Supplier and Vendor Management:Evaluate and monitor the quality of materials and components from suppliers to ensure compliance with specifications and standards.Collaborate with suppliers to address quality issues and drive improvements in the supply chain.Candidate SpecificationEducationBachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field. Advanced degree or relevant professional certification (e.g., CQE, Six Sigma) is a plus.ExperienceMinimum of 10 years of experience in quality assurance within the pharmaceutical manufacturing industry, with a strong focus on quality control and inspection. Proven experience with SAP Quality Management (QM) module implementation and optimization.Extensive experience in conducting and managing audits, including internal and external regulatory inspections.Demonstrated expertise in quality control techniques, including sampling, inspection, and testing.In-depth knowledge of quality control standards and methodologies.Strong knowledge of cGMP, ICH, WHO, EMA, USFDA, and MHRA guidelines.Proven experience in handling global regulatory inspections of EMA, USFDA, and MHRA successfully.Expertise in Quality Management Systems, Risk Management, Data Integrity, and Industry 4.0 applications in QMS.SkillsStrong leadership, communication, and interpersonal skills.Deep understanding of pharmaceutical regulations, quality management systems, and GMP practices.Proficiency in SAP QM and related modules, with hands-on experience in SAP implementation.Excellent analytical and problem-solving abilities.Ability to drive continuous improvement and manage complex quality assurance processes.Excellent leadership, communication, and cross-cultural management skills.Personal AttributesDetail-oriented with a strong commitment to maintaining high-quality standards.Proactive and results-driven, with a strategic approach to quality management.Adaptable and resilient, with the ability to manage change effectively.Strategic thinker with a proactive, results-oriented mindset.High integrity and commitment to compliance and ethical standards.Business mindset