Director, QA

Posted 10 hours 48 minutes ago by Autolus Limited

Permanent
Full Time
Other
Hertfordshire, Stevenage, United Kingdom, SG1 1
Job Description
Director, QA page is loaded Director, QAlocations: UK - Stevenagetime type: Full timeposted on: Posted 21 Days Agojob requisition id: JR100017 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: About Autolus Autolus is a clinical-stage biopharmaceutical company developing 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 that are designed to better recognise 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 and solid tumours. Why Autolus Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy 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, pension and access to an employee share scheme. Autolus promotes flexible working. 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 We are seeking an experienced and dynamic Director of Quality Assurance to lead QP Group, QA Operations and QA Compliance at our manufacturing site in Stevenage. This role is a key leadership position within the QA organisation and reports directly to the QA Site Head.The role is responsible for the oversight and execution of GMP quality systems on the manufacturing floor and across site compliance activities. It requires a strong, hands-on leader who can guide high-performing teams and maintain Autolus' quality-first culture in a fast-paced and evolving environment.Please note, this is a fully onsite position. Key Responsibilities Deputise for the Site Head of Quality for key activities such as; quality board, quality council and daily operational meetings. Lead and manage the QP group, QA Operations and QA Compliance teams at the Stevenage site. Oversee batch record review, QA shopfloor presence, product release, and deviation/CAPA management. Ensure site compliance with global GMP regulations and Autolus' internal quality standards. Serve as the QA lead for day-to-day operational quality oversight across manufacturing activities. Act as a key QA representative during regulatory inspections and internal/external audits. Foster a culture of continuous improvement, operational excellence, and quality ownership. Collaborate closely with Manufacturing, QC, Supply Chain, and Engineering to support compliant operations and timely product disposition. Maintain and enhance site quality systems in alignment with corporate quality strategy and global standards. Provide mentorship and career development for QA staff. Promote Autolus' values and patient-focused mindset in all quality-related decisions Demonstrated skills and competencies 8 years + proven experience in a senior QA leadership role within GMP biologics or advanced therapies manufacturing (cell and gene therapy experience highly desirable). In-depth understanding of global GMP regulations and guidelines (e.g., EU, MHRA, FDA). Demonstrated success managing QA Operations and/or QA Compliance teams in a manufacturing setting. Strong leadership and interpersonal skills, with the ability to engage and influence cross-functional peers. Experience supporting regulatory inspections and driving audit readiness. Excellent problem-solving, communication, and stakeholder management abilities. Qualified Person (QP) eligibility is preferred but not required.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. Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.