Title:  Sr. Manager - Quality Management System

Specific Job Description:

1. Establish compliant Quality management system to help facilitate timely, accurate and sustained decision making to assure appropriate and compliant outcomes.
2. Managing company’s Quality Management systems, Internal & Regulatory Audits, CAPA, Documentation/Change control, deviations, Customer complaints and recall programs.
3. Improve the quality management system processes by rewriting and stream lining several existing procedures to meet industry and regulatory requirements.
4. Manage the development, implementation and certification of a complete Quality Management System compliant with ISO 9001.
5. Ensure QMS compliance with relevant regulations and standards, maintaining updated knowledge of changes.

6. Developed presentations and reporting mechanism for Quality Management System metrics.
7. Managing the system of Job Descriptions and Organogram
8. Provide guidance and direction to the QMS & Documentation team to ensure proper coverage of all aspects in a GMP change

9. Lead the preparation, management, execution and support of external regulatory agency inspections and customer audits.
10. Oversee the Quality Management Plan Implementations and provide suggestions
11. Leading the Recall & Complaint functions and ensuring proper closure of topic
12. Provides leadership to achieve quality goals, develops and implements an ongoing development program for QMS processes while designing measures to monitor the effectiveness of the OMS itself and drive remediation for improvement.
13. Responsible for the Development and improvement of the Documentation team to ensure best practices are followed

14. Innovate the process of QMS & Documentation teams to reach compliance and support digitalization process
15. Support the implementation of Data Integrity principals
16. Close out of all change controls to ensure proper evidence in place
17. Review CAPA for extensions and closure of regulatory CAPA
18. Handle strategic change controls assessments and approvals
19. Follow up and resolve escalations related to batch printing
20. Manage escalations related to the QMS and regulatory commitments and properly communicate outcome to upper management

Qualification/Functional Knowledge:

1. Bachelor/Master degree in Pharmaceutical/ Life Sciences or Engineering discipline.
2. Minimum 10 years of experience with at least 7 years in management roles in pharmaceutical industry sector. Minimum 5 years of experience in paper & electronic Data Integrity.
3. Proven track record in systems initiation and KPI design
4. Ability to create cross functional relations and manage conflicts
5. Capability to provide quality solutions and managing crisis
6. Led successful quality improvement projects and cost saving procedures permitting company to meet and exceed goals in competitive environment.
7. Strong regulatory knowledge for multiple markets including GCC, EU, USA, WHO.
8. Developed various processes and procedures giving training to engineering and manufacturing with quarterly presentations to Divisional Directors and Managers.
9. Experience in training and developing staff