QA Manager, GDP Operational QA
Posted 2 days ago by Vertex Pharmaceuticals
Negotiable
Inside
Hybrid
London, England, United Kingdom
Summary: The Quality Manager at Vertex Pharmaceuticals is responsible for ensuring quality and GDP regulatory compliance in the distribution of raw materials and medicinal products. This role involves managing global processes, overseeing distribution activities, and collaborating with various stakeholders to maintain high standards of quality. The position is contract-based for 12 months and requires a proactive approach to quality management and compliance. The role is hybrid, requiring three days on-site in Paddington, London.
Key Responsibilities:
- Responsible for Quality Processes/Process Ownership for the distribution of Commercial & Clinical Finished Goods raw materials and intermediates.
- Manage an effective global shipping qualification process, including shipment qualification studies and annual shipping qualification plans.
- Execute transport lane risk assessments and optimize the use of data loggers for transport.
- Participate in inspection preparation and management for Competent Authority inspections.
- Engage in the GDP Management Review process, assessing risks and recommending mitigation approaches.
- Support Geographic Expansion activities and ensure Quality-related actions are planned and completed.
- Assist in recalls and New Product Launch activities, assessing distribution requirements.
- Serve as QA assessor on Change Controls and maintain oversight of Distribution Partners.
Key Skills:
- Knowledge of International GDP regulations; GMP and GVP regulations preferred.
- Previous GDP auditing experience and GMP experience preferable.
- Ability to learn and disseminate new information effectively.
- Strong cross-functional collaboration skills.
- Experience in leading event investigations, Root Cause Analysis (RCA), and CAPA.
- Familiarity with applications such as Oracle and Veeva.
- B.S in scientific or allied health field.
Salary (Rate): undetermined
City: London
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
Company Name: Vertex Pharmaceuticals
Type of Role : Contract position, Inside IR35
Contract length: 12 months
Location: Hybrid ( 3 days on site in Paddington )
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: The responsibilities of this position will include, but are not limited to, the following:
- Responsible in the Quality Processes/Process Ownership for the distribution of Commercial & Clinical Finished Goods raw materials and intermediates. These processes will cover controls and oversight at Vertex office operations, third party logistics providers, distribution partners, unlicensed medicines supply, wholesalers and carriers.
- 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 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
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.