Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The Group consists of five synergistic businesses focused in three areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our group of complementary businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle. Through five businesses, Clinigen Clinical Trial Services, Idis Managed Access, Idis Global Access, Link Healthcare and Clinigen Specialty Pharmaceuticals, we provide patient access to our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials. We are currently 500+ people, headquartered in Burton-on-Trent in the UK, with offices in London, Weybridge, Surrey, the US, Australia, China, Japan, South Africa and Singapore. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while physicians and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.
The role is responsible for ensuring that operations carried out within the Quality team across both Clinigen UK sites (Weybridge and Burton) are completed in accordance with the requirements of the GxP regulations and guidelines, Clinigen Quality Systems and Industry Standards. This role will represent the Quality department on assigned project teams in order to provide a consistent approach to the formulation, preparation and execution of quality actions and to also ensure that these activities are implemented in a controlled manner in line with GxP and Clinigen Global Quality expectations.
The key responsibilities for this role are:
- To perform due diligence checks and ensure suppliers and customers are qualified
- To manage authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate relevant compliance
- To demonstrate the application of activities and provisions in accordance with the Clinigen licences
- To ensure that any additional requirements imposed on certain products by national law are adhered to
- Manage the Quality release of batches and communicate with relevant QPs
- To ensure appropriate transport requirements and methods for time temperature sensitive medicinal products and hazardous products are used
- To ensure transport equipment is appropriately qualified
- Responsible for the approval of any subcontracted activities which may impact on GxP
Quality Management System (QMS):
- To follow, review and assist in the improvement of the QMS for the Clinigen Group
- To ensure customer complaints are dealt with effectively
- To coordinate and promptly action any recall operations for medicinal products and to cooperate with Marketing Authorisation Holders and Competent Authorities
- To be aware of the issues surrounding falsified medicinal products
- To manage the process of development, review and approval of Quality Technical Agreements.
- Able to practice continuous improvement and utilizes tools and techniques to solve problems
- Ensure there is a system, procedures and program to manage the validation or qualification of premises, equipment, processes and computerized systems
- To manage Quality personnel, ensuring job descriptions, objectives, personal development plans and appraisals are up-to-date and completed on time
- To ensure that Quality personnel are GxP trained and reflect the same within their duties
- To maintain training records for self and Quality, to ensure training is assessed where required
- Build and manage a high-performing, collaborative team that works in line with the Group’s values at all times.
- Ensure the appropriate level of resource and expertise is in place and that this is structured in the most effective way to deliver the strategy.
- Ensure that team have clear objectives in place and that they understand how these relate to the KPIs and the divisional and Group level strategy.
- Ensure all team members have development plans in place and regularly reviewed.
- Provide regular feedback to direct reports. Proactively address underperformance.
- Ensure effective communication of key messages to the team from across the Group.
- Recognize and celebrate success on a team and individual level.
The successful candidate will have the following:
- Qualified Person status preferred
- Substantial experience within a Pharmaceutical industry
- Extensive knowledge and experience within Quality and GxP processes
- Computer literate e.g. Word, Excel, PowerPoint, Visio
- Ability to exercise autonomy, good technical and scientific judgment, within the responsibilities defined within this job description
- Experience of developing and implementing operational plans for the areas of responsibility defined within this job description
- Ability to interpret and translate GxP guidelines into effective business strategies and processes
- Extensive people management experience
- Project management skills and able to prioritise work plans and have an ability to perform multiple tasks at one time
- Ability to initiate and maintain working relationships and communication links with the Clinigen Group, affiliated organisations and third party contractors
- Ability to put across ideas in a clear and concise manner and present a well-structured case to communicate complex information to others
- Proactive, diplomatic, self-motivating, professional with good problem solving, decision making capabilities, influencing and negotiation skills
- Advanced communication and presentation skills
- Have an understanding of the business environment in which Clinigen Group operates
- Have an appreciation of the industry sector and current competitors in the market
- Understand the customer base and is aware of customer requirements
If this role is of interest to you please upload a recent copy of your CV and a member of the Talent Acquisition team will be in touch.