Head Qualified Person
My client is a fast-growing biopharmaceuticals company based in the South-West of England.
Experts in developmental production and the bringing to market of biologicals, my client have decades of experience in production, characterisation, process and analytical validation of life saving biopharmaceuticals, including the Anthrax Vaccine.
Taking on the mantle of Head Qualified Person will see you reporting directly to the Quality Director on the delivery of autonomous and innovative Quality Management.
You will be charged with being the primary contact for all QP to QP interaction with all client customers and partners as well as managing the QP group for the release of safe and efficacious products produced to the required Quality standard.
As the Head Qualified Person, you will provide oversight and development for Quality Systems (including GxP), whilst ensuring you promote and uphold the highest standards of professionalism in order to grow the reputation of the company and ensure the best customer service for all internal and external contacts.
• Lead and manage a team of QPs responsible for certification and release of licenced medicinal products and investigational medicinal products.
• Ensure product is released in compliance with EU cGMP and the Product Specification File/marketing authorisation (or other where relevant).
• Ensure the timely review of all Batch Manufacturing Documents in accordance with manufacturing schedules and product delivery dates.
• Manage and execute the review of all deviations to assure the highest standards of compliance.
• Coach and mentor company staff to improve problem solving and early problem resolution.
• Coach and mentor other QPs within the team to enable them to meet the requirements of their roles.
• Provide input and assistance with the development of relevant elements (Batch release processes) of the Quality Management System (QMS) within the business.
• To review and approve documents within the QMS to ensure the requirements of Annex 16 are met by all QP’s.
• To undertake audits in EU and third countries to ensure that sponsor manufacturing sites are operating in general compliance with EU GMP.
• To provide advice and guidance to company staff and Customers regarding QP requirements within the EU.
• Maintain up to date knowledge of the requirements of the Medicines Authorities across the EU and rest of world (where relevant).
• Pursue a programme of continuous professional development in accordance with the requirements of QP registration and other statutory requirements.
• Review Company Project Files (PSFs, commercial project files etc.) to ensure compliance with the current regulatory requirements and company procedures.
• Provide Assistance with regulatory inspections and client audits.
Salary is negotiable on experience
Are you prepared to begin a new chapter in your career? If so, this could be the role for you! For more information and a confidential discussion, please contact Kieran Whittaker on: -
Tel: - 0161 923 8174
Email: - Kieran.email@example.com