Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a GDP Operational Quality Senior Manager.
Based in Paddington, the Sr. Quality Manager is recognised as an expert in the principles and application of quality and GDP regulatory compliance. The Sr. Quality Manager will develop global processes to support distribution of raw materials, intermediates, and medicinal products (commercial and clinical) across the 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. This position reports to the Associate Director, GDP Operational QA.
The responsibilities of this position will include, but are not limited to, the following:
* Establish robust Quality Processes /Process Ownership for the distribution of Commercial & Clinical Finished Goods. These processes will cover controls and oversight at office operations, third party logistics providers, distribution partners, unlicensed medicines supply, wholesalers and carriers.
* Establish robust Quality Processes / Process Ownership for the distribution of raw materials and intermediates. These processes will cover controls and oversights distribution between CMOs and warehouses throughout the supply chain.
* Develop and manage an effective global shipping qualification process. To ensure all routes, transportation lanes and modes of transport are qualified to execute transport lane risk assessments (to determine if a full qualification shipping study is required) to review and optimise the use of data loggers for passive or active transport to manage shipment qualification studies.
* 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 Authorisation (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 distribution requirements and expectations.
* Serve as QA assessor / approver on Change Controls: resolve gaps, approve change plans, classifications, 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.
* Master’s degree or bachelor’s degree in a scientific or allied health and strong relevant work experience.
* Ability to travel up to 30% of the time globally (not currently due to Covid-19).
* Knowledge of International GDP regulations; GMP and GVP regulations.
* Previous GDP auditing experience with GMP experience.
* Ability to learn new information and roll out to the wider audience to develop their knowledge.
* Work cross functionally with all levels to foster exceptional collaboration.
* Drive breakthrough results.
* 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 drive results.
* Adaptability / Flexibility.
* Analytical thinking / Data Analysis / Attention to detail.
* Change Management.
To be considered for this position please apply below
Product Quality Assurance