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- Tasks: Lead QA teams, oversee compliance, and ensure quality standards in a fast-paced manufacturing environment.
- Company: Join Autolus Therapeutics, an inclusive leader in the biotech industry focused on innovative therapies.
- Benefits: Enjoy a supportive culture, career development opportunities, and a commitment to diversity and inclusion.
- Why this job: Be part of a quality-first culture that impacts patient lives while working with cutting-edge therapies.
- Qualifications: 8+ years in senior QA roles, strong GMP knowledge, and leadership skills required.
- Other info: Qualified Person eligibility preferred; mentorship opportunities available.
The predicted salary is between 54000 - 84000 £ per year.
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. 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.
Director, QA employer: Autolus Therapeutics
Contact Detail:
Autolus Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, QA
✨Tip Number 1
Familiarise yourself with Autolus Therapeutics' values and culture. Understanding their patient-focused mindset and commitment to quality will help you align your approach during interviews and discussions, showcasing that you're a great fit for their team.
✨Tip Number 2
Network with current or former employees of Autolus, especially those in QA roles. They can provide insights into the company’s expectations and culture, which can be invaluable when preparing for interviews or discussions.
✨Tip Number 3
Stay updated on the latest trends and regulations in GMP biologics and advanced therapies. Being knowledgeable about recent developments will not only boost your confidence but also demonstrate your commitment to the field during conversations with the hiring team.
✨Tip Number 4
Prepare specific examples from your past experience that highlight your leadership skills and success in managing QA teams. Be ready to discuss how you've fostered a culture of continuous improvement and operational excellence in previous roles.
We think you need these skills to ace Director, QA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in QA leadership roles, particularly within GMP biologics or advanced therapies manufacturing. Emphasise any specific achievements that demonstrate your ability to manage QA Operations and Compliance teams.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of Autolus Therapeutics' mission. Mention your experience with regulatory inspections and how you can contribute to maintaining a quality-first culture.
Highlight Leadership Skills: In your application, focus on your leadership and interpersonal skills. Provide examples of how you've successfully led teams, fostered a culture of continuous improvement, and engaged with cross-functional peers.
Showcase Problem-Solving Abilities: Include specific instances where you've effectively solved problems in a QA context. This could involve managing deviations, CAPA processes, or ensuring compliance with global GMP regulations.
How to prepare for a job interview at Autolus Therapeutics
✨Showcase Your Leadership Experience
As a Director of Quality Assurance, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully led QA teams in the past, particularly in high-pressure environments. Highlight your ability to foster a quality-first culture and drive continuous improvement.
✨Understand GMP Regulations Thoroughly
Make sure you have a solid grasp of global GMP regulations and guidelines, especially those relevant to biologics and advanced therapies. Be ready to discuss how you've ensured compliance in previous roles and how you would approach maintaining standards at Autolus.
✨Prepare for Regulatory Inspection Scenarios
Since this role involves acting as a key QA representative during inspections, think about your experiences with regulatory audits. Prepare to discuss specific instances where you successfully navigated inspections or audits, and what strategies you employed to ensure readiness.
✨Emphasise Collaboration Skills
Collaboration is key in this role, so be prepared to talk about how you've worked with cross-functional teams in the past. Share examples of how you've engaged with Manufacturing, QC, Supply Chain, and Engineering to support compliant operations and timely product disposition.
