Work with us Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus. Job Description: Job Title: Senior Manager, QA Reports to: Associate Director, QA Department: QA Operations/QA Compliance Hours: 35 hour per week Location: Stevenage (Onsite) About Autolus Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases. Why Autolus Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, and pension. Our Promise Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees. Role Summary Based in Stevenage, the post holder will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for commercial purposes and clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK). You will be expected to work with a team of quality professionals to provide a high-quality service to external service users. Key Responsibilities Line manages the team and be responsible for the personnel matters of each team member. Ensures the roles and responsibilities of the team are conducted to the required standard. Manage the day-to-day activities of the team to ensure the adequate skilled and competent resources are provided to meet agreed timelines and are conducted in accordance with written policies and procedures. Design and act upon personal development plans for team staff. Train, coach and mentor other members of staff including non-Quality staff Contribute to the setting of departmental objectives and ensuring that the same are appropriately disseminated across the team. Contribute to defining the structure of the team and make recommendations to Line manager to ensure effective ways of working are maintained to provide an excellent level of support to customers. When required, prioritise team workload to release resource and enable support of other QA teams. Ensuring the team are actively contributing to the maintaining of the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies for clinical trial and commercial purposes. Support regulatory inspections – lead backroom activities and act as host, when required. Act as Project Management Lead in Quality projects and where required QA SME, in company projects. Critically assess current practices and establish new ways of working to improve efficiency and, ensure effective procedures are in place. Lead effective multi-disciplinary risk management activities (e.g.: FMEA). Host cross-functional Quality Councils when required. Any other duties as required following consultation with the post holder. The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company. Can competently and reliably perform any activity across the QA organization. Act as a technical quality expert across PDO Business Unit with the aim to effectively problem solve and remediate. Any other duties as required following consultation with the post holder. Demonstrated skills and competencies E-Essential P- Preferred Experience At least 3 years’ experience managing a team (E) At least 5 years’ experience (ideally industrial) in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system (E) Experience with MHRA or other international competent authorities (E) and HTA (P) inspections, either as host, backroom lead or involved contract giver to a manufacturing site. Qualifications BSc in pharmaceutical services, immunology, biology, chemistry or relevant discipline (P) Skills/Specialist knowledge GMP principles (E) GCP / GLP principles (P) Ability to create individual development plans and act as an effective coach and mentor. Good communications skills and ability to motivate colleagues Demonstrable ability to build strong collaborative cross-departmental relationships Skills to work within a team, understanding his/her responsibilities Good eye for detail and accurate data entry skills Good workload prioritization skills, decision-making and scheduling skills Reliability, resilience, flexibility, motivation and a responsible team-orientated attitude Ability to manage multiple activities to tight deadlines An effective influencer Autolus Core Competencies Focus on Results: Works to meet business goals set by management and leaders Builds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitments Resilience: Has the capacity to recover quickly from difficulties; toughness Communicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectives Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.