UK ~ Nottingham
Director - GMP Manufacturing Operations
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
We are currently seeking a Director GMP Manufacturing Operations to join our growing business and lead the manufacturing, supplies and facilities functions through this exciting time.
This is a great opportunity for an experienced GMP Operations Manager to define and manage CMC product manufacture, process validation, clinical manufacturing and distribution of investigational medicinal products to help meet the objectives of our company.
We are looking for candidates who not only have the technical experience to succeed, but who also have great people management skills and the ability to inspire teamwork and operational excellence. In return, you’ll join a high profile organisation and become part of an organisation where every person counts.
Main tasks and responsibilities:
As Director for GMP Operations, you will be responsible and accountable for the GMP manufacturing facility to ensure delivery of projects with respect to time, budget and quality and for developing and implementing the vision for GMP manufacturing in our Nottingham headquarters. You will:
- Set KPIs and monitor metrics to ensure continuous improvement
- Develop and execute a strategic plan for the development of GMP operations in Nottingham in terms of people, facilities and capabilities
- Manage and deliver manufacturing and supply requirements for clinical studies performed in our Nottingham facility and globally
- Work closely with Business Development and the VP of Pharmaceutical Sciences to secure new business and projects
- Review and approve key study documentation
- Develop GMP facility systems in line with company, client and regulatory requirements
- Host client/regulatory audits on behalf of Pharmaceutical Sciences
You will work alongside other leaders in the business, particularly Pharmaceutical Sciences to ensure seamless delivery of Sponsor projects. You will also have day to day responsibility for the management and direction of Manufacturing Operations, Global Clinical Trials Supplies, Facilities and Supplies departments including managing talent and succession planning within GMP operations.
The successful candidate will hold a Degree or equivalent qualification in Chemistry and significant experience within the Pharmaceutical industry, including extensive management experience in a Pharmaceutical R&D.
You will also have experience/knowledge of:
- Procedures, process and systems for a GMP/GDP compliant manufacturing facility
- The principles of operational excellence, continuous improvement and lean six-sigma
- Current manufacturing requirements for oral, parenteral and inhaled dosage forms
- Hosting and responding to QA, client and/or regulatory audits
- Early Pharmaceutical/Clinical Development
- CTA process and compiling IMPD submissions
- Working directly with clients
The role involves tight deadlines and a high concentration of work, therefore you must be able to handle multiple tasks or problems simultaneously. You will also be required to think strategically to ensure Manufacturing Operations is constantly working towards the future needs of the business through optimal utilisation of resources, monitoring annual budgets and delivering operational excellence.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.