Director, Validation

Job Summary

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)

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