QA Manager - ATMP

Due to continued growth, our CDMO client is looking for an experienced Quality Manager to join its team. Leading a team of 3, you must have previous experience in a leadership role. Previous experience working in an ATMP or Gene Therapy manufacturing environment is essential. Job Summary You will spearhead the development of a robust quality framework for the manufacturing of Advanced Therapy Medicinal Products (ATMPs) within our expanding CDMO. This role is pivotal in fostering a culture of regulatory compliance, continuous quality improvement, and quality awareness through a risk-based Pharmaceutical Quality System (PQS). You will lead a dedicated team of quality professionals while collaborating with various departments across the organization. In this role, you will oversee risk management, change control processes, and non-conformance management, ensuring compliance with the requirements of our diverse clientele and regulatory authorities. You will maintain the PQS in a state of control, identify and monitor trends, and present these findings in site management reviews. Key Responsibilities * Act as deputy to the Head of QA. * Ensure ongoing compliance of the PQS, monitoring control states and process performance. * Support the QA team and all departments in investigating and determining appropriate corrective and preventive actions (CAPAs) for quality records. * Review quality metrics and trends, lead site management review meetings, and prepare quarterly and annual quality reports. * Ensure an efficient change control process that maintains compliance. * Conduct QA reviews of batch records, ensuring timely closure of quality records impacting batches. Qualifications and Experience * MSc or equivalent experience in a life sciences discipline. * Significant experience as a quality manager within a GMP Quality department, particularly in cell and gene therapy product manufacturing. * Proven experience working with regulatory bodies and preparing sites for inspections, including MHRA and/or HTA * Demonstrated ability to manage, develop, and support a team effectively. * Strong organizational skills with the capability to prioritize tasks and work under pressure. * Ability to engage and influence senior management. This is an exciting opportunity to join a growing organization, offering a competitive salary and benefits package