Qualified Person

Job Title: Qualified Person (QP) Location: London, United Kingdom Job Type: Full-time Overview: Our client, a leading player in the gene therapy space, is seeking a highly qualified and experienced Qualified Person (QP) to join their team. This role will be critical in ensuring the highest standards of quality and compliance across the company’s clinical and commercial products. Key Responsibilities: Serve as a Qualified Person (QP) for the certification and release of products, ensuring all legal obligations under Human Medicines Regulations 2012:1916 and Clinical Trial Regulation 2004:1031 are met. Provide expertise on Good Manufacturing Practice (GMP) and ensure compliance with regulations, including the Orange Guide , Eudralex Volume 4 , and U.S. 21CFR part 210/211 . Lead the improvement of the Quality Management System (QMS) to maintain simplicity, robustness, and compliance with cGxP regulations. Foster strong relationships with internal teams and external stakeholders, including regulatory bodies and contract manufacturers. Promote a quality-driven culture across the organization, mentoring teams and building a "Quality Mindset" in those with limited GxP experience. Oversee the preparation, hosting, and follow-up of regulatory inspections . Utilize knowledge of cell culture-based manufacturing and cell and gene therapies to support production excellence. Drive continuous improvement initiatives in line with quality risk management principles . Requirements: Qualified Person Eligibility : Must be eligible to act as a QP under Human Medicines Regulations 2012:1916 and Clinical Trial Regulation 2004:1031 . GMP Knowledge : In-depth understanding of GMP as per key guidelines including Eudralex Volume 4 and U.S. 21CFR part 210/211 . Interpersonal Skills : Ability to develop effective working relationships with peers and external partners. Pharmaceutical Quality Expertise : Extensive experience in pharmaceutical Quality Assurance with a focus on pragmatic, risk-based decision-making. QMS Experience : Proven track record of building and enhancing Quality Management Systems that comply with cGxP standards. Technical Knowledge : Experience in cell culture-based manufacturing and gene therapies . Regulatory Experience : Experience in managing regulatory inspections from preparation to follow-up. Hands-On Approach : Ability to foster a quality culture , especially in teams new to GxP environments. Application Process: To apply, please submit your CV and a cover letter detailing your relevant qualifications and experience.