Director, QA

Autolus Therapeutics; London; On-site; GBP 85,000 - 120,000; Full time

Job summary

A leading biotech company in London is seeking a Director of Quality Assurance to oversee the QP Group, QA Operations, and Compliance at its Stevenage manufacturing site. The ideal candidate will have over 8 years of experience in QA leadership within GMP biologics or therapies. Responsibilities include ensuring compliance with GMP regulations, leading QA teams, and serving as QA lead during regulatory inspections. This is a key leadership position that promotes a quality-first culture.

Qualifications

• 8+ years in senior QA leadership role within GMP biologics or therapies manufacturing.
• In-depth understanding of global GMP regulations (EU, MHRA, FDA).
• Experience managing QA Operations and compliance in manufacturing.

Responsibilities

• Lead QP group, QA Operations, and QA Compliance teams.
• Ensure site compliance with GMP regulations and internal quality standards.
• Act as QA lead during regulatory inspections and audits.

Skills

Proven experience in senior QA leadership

Understanding of global GMP regulations

Strong leadership and interpersonal skills

Experience supporting regulatory inspections

Excellent problem-solving abilities

Job description

Job 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.

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.
  
  

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