QA Manager, GDP Operational QA

This is a 12-month contract, with an immediate start. The role offers hybrid working, with occasional travel to London. Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

General Summary: The Quality Manager is responsible for the principles and application of quality and GDP regulatory compliance. The Quality Manager will support the development of global processes for distribution of Vertex’s raw materials, intermediates, and medicinal products (commercial and clinical) across its global distribution network. This role supports GDP operations for all distribution activities globally; key stakeholders include Operations QA, International Supply chain, demand planning, logistics, Geographic expansion, QMS/OMS QA, Vendor Management & AIM QA.

Key Duties and Responsibilities:

• Responsible in the Quality Processes/Process Ownership for the distribution of Commercial & Clinical Finished Goods raw materials and intermediates.
• Proactively manage an effective global shipping qualification process.
• Shipment qualification studies.
• Annual shipping qualification plan.
• Ensure all routes, transportation lanes and modes of transport are qualified.
• Execute transport lane risk assessments (to determine if a full qualification shipping study is required).
• Review and optimize the use of data loggers for passive or active transport.
• Participate in inspection preparation and management, prior to, during and following any Competent Authority inspection of international locations; Support manufacturing locations as required.
• Participate in 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 in-market activity.
• Support in New Product Launch activities to assess new territories distribution requirements and expectations.
• Serve as QA assessor on Change Controls: resolve gaps and identify strategy for GDP/GMP actions.
• Have a knowledge of GDP regulations and requirements and remain up to date.
• Day to day oversight of Distribution Partners, including: Preparation and maintenance of Quality Agreements, Review of deviations, CAPA and changes identified, Maintaining KPIs.

Knowledge and Skills:

• Knowledge of International GDP regulations; GMP and GVP regulations as a preference.
• Previous GDP auditing experience, GMP experience preferable.
• Ability to learn new information and roll out to the wider audience to develop their knowledge.
• Work cross functionally to foster exceptional collaboration.
• Leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Applications such as Oracle and Veeva.

Education and Experience:

• B.S in scientific or allied health field.