Job Summary:
The Global Quality Assurance Manager will oversee the development and implementation of a comprehensive Quality Management System (QMS) for DP World, with a strong emphasis on health logistics. This role will ensure adherence to global regulatory standards, drive uniform GXP practices across regions, manage risks associated with health product logistics, and uphold global quality and accreditation requirements.
Key Responsibilities:
- Quality Management System Implementation:
- Develop and enforce high standards of quality and regulatory compliance worldwide, adhering to GXP guidelines.
- Create and implement procedures to ensure regulatory adherence and effective risk management throughout the health and pharmaceutical supply chain.
Regional Quality Management Standardization: - Lead and guide regional quality managers in the harmonization and execution of quality management practices.
- Conduct quality inspections and audits, and generate reports for health logistics operations across all regions.
Regulatory Compliance and Risk Management: - Ensure adherence to Good Distribution Practices (GDP) and other applicable standards.
- Manage and coordinate with global regulatory bodies and Ministries of Health to meet regional requirements.
- Supplier Support and Evaluation:
- Perform regular internal audits and quality assessments for suppliers.
- Develop and implement techniques to enhance the quality, reliability, and safety of healthcare logistics.
- Training and Development:
- Identify and address training needs to ensure compliance with quality standards.
- Create and deliver communication strategies to enhance awareness of quality assurance standards, GXP requirements, program updates, and process changes.
- Disaster Recovery and Incident Management:
- Establish disaster recovery plans in collaboration with Global Health and Safety.
- Lead and manage resolution efforts for quality or regulatory incidents impacting products and operational practices.
- KPI Monitoring and Enhancement:
- Track and analyze Key Performance Indicators (KPIs) related to receiving times, processing times, warehouse efficiency, stock loss, and picking accuracy.
- Drive company-wide initiatives to improve quality in healthcare logistics.
- Liaison and Representation:
- Serve as a key point of contact for external stakeholders on quality management issues related to healthcare logistics.
- Represent DP World during authority inspections and client audits.\
- Daily Responsibilities:
- Global Quality Management System (QMS): Implement, maintain, and enhance the QMS on a global scale.
- Process Optimization: Initiate and support initiatives to optimize processes and update Standard Operating Procedures (SOPs) as needed.
- GMP and GDP Expertise: Serve as the internal and external authority on Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Audits: Conduct and follow up on physical audits of external manufacturing sites, warehouses, depots, and transporters to ensure compliance with GMP/GDP standards.
- Service Provider Qualification: Qualify and re-qualify external service providers, customers, and suppliers for GMP/GDP-related services.
- Internal Audits: Perform internal audits (self-inspections) to verify adherence to GMP/GDP and internal quality standards.
- Training and Agreements: Conduct cross-functional internal training sessions and develop quality agreements.
Qualifications, Skills, and Experience:
- Educational Background: University degree in natural sciences (e.g., BSc, BPharm).
- Professional Experience: At least 12 years of experience in Quality Assurance (QA), Good Practice (GXP), and Good Distribution Practice (GDP) on a global scale within the pharmaceutical logistics sector.
- Industry Expertise: Proven expertise in quality management and regulatory practices in the pharmaceutical industry, including Warehousing, Distribution, Freight Forwarding, and Global Logistics.
- Previous Roles: Experience in a Qualified Person (QP) or Responsible Person (RP) role within a supply chain or pharmaceutical organization is advantageous.
- Regulatory Knowledge: Familiarity with regulations and quality controls for global storage and distribution of pharmaceutical products, as well as various Ministries of Health regulations.
- Certifications: Knowledge of ISO accreditation, TAPA certification, and quality management systems.
- GXP Expertise: Extensive understanding of GXP, GMP, and GDP requirements.
- Leadership and Project Management: Strong leadership and project management capabilities.
- Communication Skills: Excellent communication and interpersonal skills, with sensitivity to cultural diversity and the ability to work effectively across different regions.
- Interpersonal Skills: Effective communication with Board members, executives, and senior-level staff.
- Attention to Detail: Meticulous attention to detail and exceptional organizational skills.