Director, QA

Autolus Therapeutics; Stevenage; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in Stevenage seeks a Director of Quality Assurance to oversee QA operations and compliance. This key leadership role demands strong leadership skills and a deep understanding of GMP regulations. The ideal candidate will foster a quality-first culture and ensure compliance with manufacturing standards while mentoring QA staff.

Qualifications

• 8+ years in senior QA leadership role within GMP biologics.
• In-depth understanding of global GMP regulations.

Responsibilities

• Lead and manage QA Operations and QA Compliance teams.
• Ensure compliance with global GMP regulations.
• Act as QA lead during regulatory inspections.

Skills

Leadership

Problem Solving

Communication

Stakeholder Management

Job description

Job Description

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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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