Sr Manager - Quality Management System

TALENTMATE; Ras Al Khaimah; On-site; AED 300,000 - 540,000; Full time

Job summary

Julphar in Ras Al Khaimah seeks an experienced Quality Assurance leader to establish and manage a compliant QMS aligned with ISO 9001. You will oversee audits, CAPA, change control, and regulatory readiness across GCC/EU/USA/WHO markets, guiding a cross-functional team to ensure excellence in pharma quality.

The role emphasizes data integrity, process improvement, training, and strategic handling of regulatory inspections and recalls within a growing manufacturing environment.

Qualifications

• Bachelor/Master degree in Pharmaceutical, Life Sciences or Engineering.
• 10+ years in pharma with at least 7 years in management roles; 5 years in data integrity (paper & electronic).
• Proven track record in systems initiation and KPI design.
• Regulatory knowledge for GCC, EU, USA, WHO.
• Experience training and developing staff.

Responsibilities

• Establish compliant QMS to enable timely, accurate decision making.
• Manage QMS, Internal & Regulatory Audits, CAPA, Documentation/Change control, deviations, complaints and recalls.
• Improve QMS processes by rewriting and streamlining procedures to meet regulatory requirements.
• Lead development and certification of a complete QMS compliant with ISO 9001.
• Ensure QMS compliance with relevant regulations and standards, updating knowledge of changes.
• Develop presentations and reports for QMS metrics.
• Provide guidance to QMS & Documentation team for GMP changes.
• Lead external regulatory inspections and customer audits.

Skills

QMS Leadership

Regulatory Knowledge

CAPA Management

Data Integrity

Cross-functional Collaboration

Quality Assurance

Crisis Management

Education

Bachelor/Master in Pharma/Life Sciences or Engineering

Job description

Job Description

• 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 updated knowledge 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 proper coverage 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 to ensure 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

Qualifications / Functional Knowledge

• Bachelor/Master degree in Pharmaceutical/ Life Sciences or Engineering discipline.
• 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.
• 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 permitting company to meet and exceed goals in competitive environment.
• Strong regulatory knowledge for multiple markets including GCC, EU, USA, WHO.
• Developed various processes and procedures giving training to engineering and manufacturing with quarterly presentations to Divisional Directors and Managers.
• Experience in training and developing staff

Job Details

Role Level: Executive-Level
Work Type: Full-Time
Country: United Arab Emirates
City: Ras Al Khaimah
Company Website: http://www.julphar.net
Job Function: Quality Assurance & Control
Company Industry: Pharmaceutical Manufacturing
Sector: Pharmaceutical Manufacturing