Sr. Manager - Quality Management System

Julphar; United Arab Emirates; On-site; AED 180,000 - 300,000; Full time

Job summary

Julphar in the United Arab Emirates seeks a senior Quality Management professional to establish and maintain a compliant QMS, lead audits, CAPA, documentation, change control, deviations, and recalls while ensuring regulatory alignment. The ideal candidate holds a Bachelor/Master in Pharmaceutical/Life Sciences or Engineering, with 10+ years in pharma, including 5+ years in data integrity and management.

You will guide the QMS and Documentation teams, drive improvements, and interact with GCC,

Qualifications

• Bachelor/Master degree in Pharmaceutical/ Life Sciences or Engineering.
• Minimum 10 years of experience with at least 7 years in management roles in pharmaceutical sector.
• Minimum 5 years of experience in paper & electronic Data Integrity.
• Proven track record in systems initiation and KPI design.
• Ability to create cross functional relations and manage conflicts.
• Capability to provide quality solutions and managing crisis.
• Led successful quality improvement projects and cost saving procedures.
• Strong regulatory knowledge for multiple markets including GCC, EU, USA, WHO.
• Experience in training and developing staff.

Responsibilities

• Establish compliant Quality management system to help facilitate timely, accurate and sustained decision making to assure appropriate and compliant outcomes.
• Managing company’s Quality Management systems, Internal & Regulatory Audits, CAPA, Documentation/Change control, deviations, Customer complaints and recall programs.
• Improve the quality management system processes by rewriting and stream lining several existing procedures to meet industry and regulatory requirements.
• Manage the development, implementation and certification of a complete Quality Management System compliant with ISO 9001.
• Ensure QMS compliance with relevant regulations and standards, maintaining updatedknowledge of changes.
• Developed presentations and reporting mechanism for Quality Management System metrics.
• Managing the system of Job Descriptions and Organogram
• Provide guidance and direction to the QMS & Documentation team to ensure propercoverage of all aspects in a GMP change.
• Lead the preparation, management, execution and support of external regulatory agency inspections and customer audits.
• Oversee the Quality Management Plan Implementations and provide suggestions
• Leading the Recall & Complaint functions and ensuring proper closure of topic
• 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.
• Responsible for the Development and improvement of the Documentation team toensure best practices are followed
• Innovate the process of QMS & Documentation teams to reach compliance and support digitalization process
• Support the implementation of Data Integrity principals
• Close out of all change controls to ensure proper evidence in place
• Review CAPA for extensions and closure of regulatory CAPA
• Handle strategic change controls assessments and approvals
• Follow up and resolve escalations related to batch printing
• Manage escalations related to the QMS and regulatory commitments and properly communicate outcome to upper management

Skills

KPI design

Cross-functional collaboration

Quality solutions

Crisis management

Regulatory knowledge

Leadership/management

Data Integrity

Education

Bachelor/Master degree in Pharmaceutical/ Life Sciences or Engineering discipline

Job description

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 updatedknowledge of changes.

1. Developed presentations and reporting mechanism for Quality Management System metrics.


2. Managing the system of Job Descriptions and Organogram


3. Provide guidance and direction to the QMS & Documentation team to ensure propercoverage of all aspects in a GMP change

1. Lead the preparation, management, execution and support of external regulatory agency inspections and customer audits.


2. Oversee the Quality Management Plan Implementations and provide suggestions


3. Leading the Recall & Complaint functions and ensuring proper closure of topic


4. 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.


5. Responsible for the Development and improvement of the Documentation team toensure best practices are followed

1. Innovate the process of QMS & Documentation teams to reach compliance and support digitalization process


2. Support the implementation of Data Integrity principals


3. Close out of all change controls to ensure proper evidence in place


4. Review CAPA for extensions and closure of regulatory CAPA


5. Handle strategic change controls assessments and approvals


6. Follow up and resolve escalations related to batch printing


7. 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