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- Tasks: Lead the CQV function, ensuring compliance and operational readiness at our Stevenage site.
- Company: Join Autolus Therapeutics, a diverse employer committed to innovation in the biotech industry.
- Benefits: Enjoy a collaborative culture, professional development opportunities, and a focus on continuous improvement.
- Why this job: Be part of a team that drives impactful change in cell and gene therapy while fostering a supportive environment.
- Qualifications: 10+ years in CQV within GMP settings; leadership experience is essential.
- Other info: This role offers a chance to shape the future of biopharmaceuticals in a dynamic setting.
The predicted salary is between 72000 - 108000 £ per year.
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.
Role Summary
The Director, Validation (CQV) will be responsible for leading the Commissioning, Qualification, and
Validation (CQV) function at Autolus’ Stevenage site. This role is critical to ensuring that all GMPcritical
facilities, utilities, and equipment are qualified and maintained in a validated state in
accordance with applicable regulatory requirements and Autolus standards. The Director will lead a
team of CQV professionals and will work closely with cross-functional teams to support operational
readiness, capital projects, and facility expansions.
Key Responsibilities
• Leadership & Oversight: Lead the site CQV function and team, overseeing all qualification
activities related to GMP facilities, utilities, and equipment.
• Validation Master Plan (VMP): Own and maintain the site-specific VMP, ensuring alignment with
global and site strategy.
• Regulatory Compliance: Ensure all CQV activities comply with current regulatory requirements
(e.g., EU GMP Annex 15, FDA guidelines), internal policies, and industry best practices.
• Cross-Functional Collaboration: Partner with Engineering, Manufacturing, Warehouse, Quality
Control (QC), Quality Assurance (QA), and Facilities to maintain qualified systems in a validated
state.
• Capital Project Support: Provide CQV leadership across all project phases, including development
of URS, FAT/SAT execution, DQ/IQ/OQ/PQ, and preparation of final reports.
• Regulatory Interface: Act as the Subject Matter Expert (SME) for CQV during regulatory
inspections and internal/external audits.
• Lifecycle & Risk-Based Approach: Champion lifecycle and risk-based qualification strategies in
accordance with ICH Q9 and Q10 principles.
• Continuous Improvement: Drive improvements in CQV processes and systems to enhance
efficiency, ensure compliance, and support scalability.
• Resource Management: Manage internal CQV staff and external vendors/contractors to ensure
timely and high-quality execution of activities.
• Team Development: Recruit, mentor, and develop a high-performing CQV team, fostering a
strong culture of quality, collaboration, and continuous learning
Demonstrated skills and competencies
• Degree in Engineering, Life Sciences, or a related technical discipline (E)
• Minimum of 10 years' experience in Commissioning, Qualification, and Validation within a
GMP pharmaceutical or biotechnology environment (E)
• At least 5 years of experience in a leadership role managing CQV teams or programs (E)
• Expert understanding of EU GMP Annex 15, FDA requirements, ISPE Baseline Guide Vol. 5,
GAMP 5, and related industry guidance
• Demonstrated experience with GMP facility commercial operations and , improvement
projects, automation projects within GMP facilities, and major equipment commissioning and
qualification (E)
• Strong understanding of risk-based qualification principles and quality risk management tools
(E)
• Proven ability to lead cross-functional projects in a fast-paced, regulated environment (E)
• Excellent communication, stakeholder management, and decision-making skills (E)
• Experience in cell and gene therapy, ATMPs, or sterile manufacturing environments (D)
• Experience working within a multi-product commercial facility (E)
• Experience managing third-party vendors, CQV consultants, or EPCM partners (D)
• Lean Six Sigma or similar continuous improvement certification (D)
• Advanced degree (MSc, MBA, etc.) in a relevant technical discipline (D)
#LI-DNI
Director, Validation employer: Autolus Therapeutics
Contact Detail:
Autolus Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Validation
✨Tip Number 1
Familiarise yourself with the latest EU GMP Annex 15 and FDA guidelines. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance, which is crucial for the Director, Validation role.
✨Tip Number 2
Network with professionals in the CQV field, especially those who have experience in cell and gene therapy or sterile manufacturing environments. Engaging with industry peers can provide insights and potentially lead to referrals that could strengthen your application.
✨Tip Number 3
Prepare to discuss your leadership experiences in managing CQV teams. Be ready to share specific examples of how you've driven continuous improvement and fostered a culture of quality within your teams, as this is a key aspect of the role.
✨Tip Number 4
Research Autolus Therapeutics and their recent projects or initiatives. Showing that you understand their mission and how your skills align with their goals can set you apart during the interview process.
We think you need these skills to ace Director, Validation
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Commissioning, Qualification, and Validation within a GMP environment. Emphasise leadership roles and specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the role and how your background fits the requirements. Mention your experience with regulatory compliance and cross-functional collaboration, as these are key aspects of the position.
Highlight Relevant Skills: In your application, clearly outline your expertise in EU GMP Annex 15, FDA guidelines, and risk-based qualification principles. Use specific examples to demonstrate your knowledge and how it applies to the role at Autolus Therapeutics.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is clear, concise, and professional, reflecting your attention to detail, which is crucial for this role.
How to prepare for a job interview at Autolus Therapeutics
✨Showcase Your Leadership Experience
As a Director, Validation, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully led teams in the past, particularly in CQV roles. Highlight any specific challenges you faced and how you overcame them.
✨Understand Regulatory Requirements
Familiarise yourself with EU GMP Annex 15 and FDA guidelines, as these are crucial for the role. Be ready to discuss how you've ensured compliance in previous positions and how you would approach regulatory inspections.
✨Emphasise Cross-Functional Collaboration
This role requires working closely with various departments. Prepare to discuss your experience collaborating with Engineering, Manufacturing, and Quality teams. Share specific examples of successful projects that involved cross-functional teamwork.
✨Demonstrate Continuous Improvement Mindset
Autolus values continuous improvement in CQV processes. Be prepared to talk about initiatives you've led or contributed to that enhanced efficiency or compliance. Discuss any Lean Six Sigma or similar methodologies you've applied.
