Title:  Process Lead - Quality Management System

Detailed Job Description

1. Establish and manage Quality Management Systems (QMS), monitoring performance through KPIs, and regularly reporting outcomes to top management while ensuring the reflection of monthly data in the Quality Council.
2. Provide insightful analysis of QMS & KPIs to assess site performance, identify areas for improvement, and support overall quality enhancement initiatives.
3. Develop a framework for Corrective and Preventive Actions (CAPA) and ensure its alignment with Change Control, Complaints, Recalls, Deviations, Documentation, Job Descriptions, and Organizational Structures.
4. Ensure compliance with the Site Master File, Quality Manual, ISO standards, and the Medical Check-Up system.
5. Streamline systems and create a user-friendly environment while upholding high quality standards.
6. Design and implement an effective CAPA system, ensuring root-cause analysis and problem-solving activities lead to appropriate corrective and preventive actions.
7. Establish a compliant Quality Management System to facilitate timely, accurate, and sustained decision-making for appropriate and compliant outcomes.
8. Oversee the company’s QMS, including Internal & Regulatory Audits, CAPA, Documentation/Change Control, Deviations, Risk Management, Customer Complaints, and Recall programs.
9. Enhance QMS processes by revising and optimizing existing procedures to meet industry and regulatory standards.
10. Manage the development, implementation, and certification of a fully compliant Quality Management System (ISO 9001).
11. Ensure QMS compliance with relevant regulations and standards, staying updated on changes and ensuring ongoing compliance.
12. Develop presentations and reporting mechanisms to effectively communicate QMS metrics.
13. Administer the system for Job Descriptions and Organizational Structures (Organogram).
14. Guide and support the QMS & Documentation team to ensure comprehensive coverage of all GMP change-related aspects.
15. Lead the preparation, execution, and support of external regulatory inspections and customer audits.
16. Oversee the implementation of the Quality Management Plan, providing recommendations for continuous improvement.
17. Lead the Recall & Complaint management functions, ensuring timely and thorough resolution of issues.
18. Provide leadership to achieve quality goals, continuously develop QMS processes, and design measures to assess the effectiveness of the Quality Management System, driving remediation efforts.
19. Guide the development and enhancement of the Documentation team, ensuring best practices are followed in all aspects.
20. Drive innovation within the QMS & Documentation teams, supporting digitalization efforts and compliance with industry standards.
21. Support the implementation of Data Integrity principles to ensure accuracy and security of data.
22. Ensure timely closure of all change controls, ensuring appropriate evidence and documentation are in place.
23. Review CAPA actions for extensions and regulatory CAPA closure.
24. Oversee strategic assessments and approvals for change controls.
25. Address and resolve escalations related to batch printing issues.
26. Manage escalations related to QMS and regulatory commitments, effectively communicating outcomes to upper management. Lead the preparation, management, execution and support of external regulatory agency inspections and customer audits.

Core Competency

1. In-depth expertise in Quality Management Systems (QMS).
2. Strong technical background in GMP-related areas, with comprehensive knowledge of regulatory standards and audit procedures.
3. Effective leadership and motivational abilities for team management.
4. Proficient problem-solving skills.
5. Extensive technical knowledge in relevant fields.
6. Strong communication and presentation abilities.
7. Thorough understanding of quality improvement tools and continuous improvement methodologies.
8. Excellent business acumen, with a focus on cost efficiency and financial awareness.
9. Results- and process-driven, committed to achieving both personal and departmental goals.
10. Adaptable with strong change management capabilities.
11. Solution-oriented mindset with sound decision-making skills.
12. Exceptional team-building skills, with strong time and task management for both personal and team success.

Qualification/Functional Knowledge

1. Bachelor’s degree in pharmacy. A master’s degree or higher qualification is preferred. 
2. Professional certification in Quality Management or a related field (e.g., ASQ Certified Quality Manager) is a plus. 
3. A minimum of 7 years of experience in quality management within the pharmaceutical industry preferably in Quality Management systems,
4. In-depth knowledge of GMP, FDA regulations, and other relevant regulatory standards. 
5. Strong analytical, problem-solving, and communication skills. 
6. Proficient in MS Word, Excel, and PowerPoint