Quality Manager - Distribution/ Logistics
Our client is a rapidly growing pharmaceutical company with headquarters in Central London. They are currently seeking a Quality Manager to work within their Distribution and Logistics group. Reporting to the Quality Director, the Quality Manager will be for the compliance to Good Distribution Practice (GDP) for the global supply chain of company products. You will ensure that products distributed by, and on behalf of the company are stored and transported in compliance with all applicable licenses and regulations. The role will require some international travel to outsourced service providers.
- Establish a close working relationship with the outsourced distribution and logistics providers.
- Support the Responsible Person in fulfilling their duties as per GDP regulations through:
- Ensuring that distributors, and logistic providers are approved and monitored.
- Coordinating and promptly performing any recall operations
- Conducting mock recalls.
- Bona Fide checks of customers where required.
- Ensuring appropriate transport conditions (temperature and security) are maintained and, where applicable, validated.
- Assessing and documenting any temperature deviations for quality impact.
- Maintaining the necessary and appropriate wholesale dealer's authorisations.
- Performing or supporting audits of applicable outsourced service providers of storage / transportation.
- Establishing and maintaining robust Quality Agreements with all outsources service providers.
- Supporting the product compliance team with in-market release of product.
- Investigation of complaints relating to storage and distribution.
- Initiating change controls where necessary.
- Provide GDP training to internal stakeholders.
- Establishing global supply chain maps for all products through close working with internal stakeholders.
- Support strategic acquisitions, expansion or additions to the global distribution of company products.
- Support on-site GDP audits by Regulatory Authorities and, where required, Customers.
- Keep up to date with the latest Regulations and support their implementation
- Author and approval of Standard Operating Procedures
- Input to and support of the Quality Management Review process
Skills and Requirements:
- Experience working in Quality Assurance within the Pharmaceutical industry.
- Broad experience of all areas of GDP and working with global supply chains.
- Experience of working with and managing outsourced service providers
- Extensive Knowledge of the EC Guideline 2013/C 343/01 on Good Distribution Practice of medicinal products
- Able to foster strong cross-functional relationships.
- Excellent influence, interpersonal, verbal and written communication skills.
- Able to respond positively to, and effectively implement, change.
- Strong analytical and investigative skills to proactively solve problems.
- Commercial / financial awareness of global supply chains.
- Digitally Savvy
- A degree or equivalent in a relevant scientific subject is desirable
- Previous experience as a Responsible Person on a WDA(H) is desirable
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.