The Quality Senior Manager will develop global processes to support distribution of Vertex’s raw materials, intermediates, and medicinal products across the region.

 

This role supports GDP operations and local activities; key stakeholders include Operations QA, International Supply chain, demand planning, logistics, Geographic expansion, QMS/OMS QA, Vendor Management & AIM QA.

 

 

Key Responsibilities:

  • Establish robust Quality Processes/Process Ownership for the Commercial & Clinical Finished Goods and for the distribution of raw materials and intermediates
  • Develop and manage an effective global shipping qualification process
  • Define a process outlining requirements for only using qualified vendors for logistics
  • Support Inspection preparation and management, prior to, during and following any Competent Authority inspection of international locations; Support manufacturing locations as required
  • Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
  • Participate in Geographic Expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Wholesale Dealers Authorization (or equivalent) application, audits, and Quality Agreements.
  • Support recalls, mock recalls and any other on-market activity.
  • Support in New Product Launch activities to assess new territories requirements and expectations.
  • Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.

 

Key Requirements:

  • Bachelor’s degree in a scientific or allied health field (or equivalent degree)
  • Expert knowledge of regional GDP/GMP requirements governing products and procedures knowledge
  • Knowledge of International GDP regulations
  • Previous GDP auditing experience
  • Strong collaboration skills with the ability to thrive in a high throughput environment
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Ability to collaborate cross functionally across all levels of the organization
  • Ability to design, develop and deliver effective training
  • Analytical thinking / Data Analysis/ Attention to detail
  • Change Management
  • Critical thinking / Problem solving / decision making
  • Skilled at time and resource management and prioritization, planning and organization skills
  • Ability to communicate, influence, conflict management’ ability to understand and translate internal customer needs
  • Fluent in both English and Arabic
  • Ability to travel within the region and internationally, as required.

 

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

 

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Tagged as: Pharmaceuticals

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