Scotland - central belt
Competitive based upon experience
My client is a ground-breaking biotech company developing and commercialising innovative cell-based products to treat disease, improving patient health and Quality of Life. They use novel immunotherapy to develop cell-based treatments for cancer and severe viral infections.
Due to continuous growth in the company, my client is now looking for a driven, organised and proactive individual to join their team as a Qualified Person. The successful candidate will enjoy a diverse role providing leadership and direction to an integrated quality operations function. As an integral member of the site leadership team, this includes ensuring that operations on site are being conducted according to all internal and external quality and regulatory compliance requirements.
My client’s unique culture, values and working environment attracts, retains, and inspires people to give their best. So, if you have an affinity for quality assurance and want to put your brainpower towards aiding the development of world-changing research in a dynamic team environment, please apply;
What you will do:
• Leading, developing, and managing the strategic and operational performance of the Quality Operations function (QA and QC)
• Performing Batch Certification of IMPs produced at the company for use in EU Clinical Trials
• Providing general GMP compliance oversight and advice for manufacturing and QC testing
• Managing and developing structures, policies, processes, and procedures to ensure effective and accountable use of resources across the Quality operations function
• Managing and ensuring that the quality management systems, processes, and procedures are implemented across the manufacturing facilities to ensure that product released is fit for use and is compliant with appropriate regulatory commitments
• Taking financial accountability for the control of the Quality operations budget
• Representing the company to authorities and service providers on all quality matters.
• Contributing to the site performance as agreed through the performance management objectives on the basis of informed advice on quality requirements
• Being responsible for the development, collating, and reporting of key quality and business metrics to drive a culture of continuous process improvement
• Ensuring that systems and processes for the management of complaints and product recalls are being conducted in accordance with the licensed risk management systems
• Advising on compliance requirements and strategies for process development and technology transfer activities
• Planning, co-ordinating, interpreting, and compiling relevant information necessary for regulatory submission to ensure successful granting, maintenance, and variations of licences
• Being responsible for the co-ordination and preparation of regulatory submissions and strategies.
• Developing and maintaining regulatory knowledge of EU/FDA regulations and potentially other territories.
What you will need:
• Degree level education in a sciences discipline or QA discipline to be eligible to act as a QP for Investigational Medicinal Products as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004
• Have significant experience in a GMP QA role within the pharmaceutical or related industry as well as QMS process design, implementation, management, and utilisation experience
• Have outstanding knowledge of GMP and related processes
• Be experienced in EU and FDA cGMP and regulatory requirements for the manufacture, testing, and licensure of products within a biologics manufacturing environment
• Have excellent communication and interpersonal skills
What you will get:
• Great Benefits Package
• Highly competitive salary
This an exciting opportunity to join an emerging cancer immunotherapy company developing cell-based treatments in a senior management role. Get in touch today to ensure that you don’t miss out!
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