Senior Quality Manager, GDP Operational Quality, 12 month FTC
Vertex Pharmaceuticals
- Paddington, West London
- Permanent
- Full-time
- Responsible in the Quality Processes/Process Ownership for the distribution of Commercial & Clinical material movement. 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.
- 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 strong knowledge of GDP regulations and requirements.
- Day to day oversight of Distribution Partners, including:
- Preparation and maintenance of Quality Agreements
- Review of deviations, CAPA and changes identified
- Maintaining KPIs
- Escalation of issues
- Support late stage customization operations performed on behalf of, or by a commercial partner
- Bachelor’s degree in a scientific or allied health field (or equivalent degree) and relevant work experience, or relevant comparable background
- Knowledge of International GDP regulations; GMP and GVP regulations
- Previous GDP auditing experience, GMP experience preferable.
- Ability to learn new information and roll out to the wider audience to develop their knowledge.
- Strong leadership 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
- Ability to drive results
- Adaptability /Flexibility
- Analytical thinking / Data Analysis/ Attention to detail
- Change Management
- Continuous Process improvement
- Critical thinking / Problem solving / decision making
- Project Management- time and resource management and prioritization, planning and organization skills
- Relationship Management skills- communication, influence, conflict management, ability to understand and translate customer needs
- Strategic thinking / forward thinking / planning
- Technical writing
- Expert knowledge of global GDP/GMP requirements governing oral drug products and knowledge of product manufacturing practices