Quality Assurance Leader - GCP and AAV Development

Cpl Life Sciences; Greater London; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Stealth Mode Biotechnology Company, an AAV gene therapy developer, is seeking a hands-on Quality Assurance Leader to establish the QA function from the ground up in West London (Hybrid). You will shape quality culture, systems, and governance across clinical development, CMC, and external partners.

As the first QA hire, you will lead GxP compliance, CTA support, and risk-based quality management while partnering with senior leadership to embed quality into every program.

Qualifications

• Degree in Life Sciences, Pharmacy, Biotechnology or related field.
• Significant QA experience in biotech or CRO environments.
• Strong knowledge of GCP and sponsor-side requirements.
• Experience implementing quality systems and processes.
• Experience supporting CTAs and regulatory submissions.
• Experience overseeing outsourced vendors and CDMOs.
• Strong risk-based quality management and stakeholder influence.
• Ability to operate in fast-paced, entrepreneurial environment.

Responsibilities

• Establish and lead the quality function as the first QA hire.
• Develop scalable quality strategy aligned to growth.
• Build quality systems, SOPs, and governance.
• Provide QA leadership for CTA prep, submissions, and audits.
• Ensure inspection readiness and vendor oversight.
• Drive continuous improvement and quality metrics.

Skills

GCP knowledge

Quality leadership

Regulatory submissions

Vendor oversight

Risk-based QA

Education

Degree in Life Sciences or related field

Job description

Job Title: Quality Assurance Leader – AAV development

Job Type: Full time, permanent role

Job Location: West London, UK (Hybrid)

Remuneration: Competitive salary and package

Stealth Mode Biotechnology Company, AAV Gene Therapy | Clinical Stage Assets

Cpl Life Sciences is partnering with a highly innovative, well-funded biotechnology company operating in stealth mode. The business is developing a pipeline of next-generation AAV-based therapies and is entering a pivotal period of growth as it advances programmes towards the clinic.

We are seeking an experienced and hands‑on Quality Leader to become the company’s first dedicated Quality hire. This is a rare opportunity to build and shape the Quality function from the ground up, establishing the quality culture, systems, processes, and governance that will support the development and delivery of transformative gene therapies.

You will act as the quality representative across clinical development, regulatory affairs, CMC, external manufacturing partners, and strategic vendors. You will be responsible for establishing GCP standards and quality frameworks across the business whilst providing oversight of all quality‑related activities associated with clinical trial applications (CTAs), clinical operations, and AAV development programmes.

This role requires someone who enjoys building rather than maintaining, can operate in a fast‑moving environment, and is comfortable working autonomously whilst influencing senior stakeholders across the organisation.

Key Responsibilities

• Establish and lead the company’s Quality function as the first dedicated QA professional.
• Develop and implement a scalable quality strategy aligned to the company’s growth plans and clinical ambitions.
• Build quality systems, policies, SOPs, governance structures, and quality culture across the organisation.
• Act as the subject matter expert for GxP compliance and quality‑related decision making.
• Partner with executive leadership to ensure quality is embedded across all functions.

Clinical Quality & GCP Oversight

• Develop and maintain the sponsor‑side GCP Quality Management System.
• Establish quality standards, procedures, and oversight models to support global clinical studies.
• Provide quality leadership throughout CTA preparation, submission, approval, and execution activities.
• Ensure inspection readiness and ongoing compliance across all clinical programmes.
• Oversee CROs, clinical vendors, laboratories, and trial sites through risk‑based quality management approaches.
• Lead quality event management including deviations, CAPAs, investigations, root cause analysis, and continuous improvement activities.
• Support audit planning, execution, and follow‑up activities.

Regulatory & CTA Support

• Provide QA review and oversight of CTA documentation and supporting submissions.
• Collaborate closely with Regulatory Affairs to ensure compliance with applicable global regulations and quality expectations.
• Support interactions with regulatory authorities and inspection activities.
• Ensure quality considerations are integrated into development plans and regulatory strategies.

CMC, GMP & External Partner Oversight

• Provide quality oversight of CDMOs and manufacturing partners supporting AAV development and production.
• Support qualification, auditing, and ongoing management of external partners.
• Ensure robust oversight of GMP activities supporting clinical development.
• Manage the GMP‑GCP interface, including product traceability, handling, storage, distribution, and accountability.
• Support quality review of manufacturing changes, investigations, deviations, and supplier quality activities.

Quality Systems & Continuous Improvement

• Build, implement, and maintain fit‑for‑purpose quality systems.
• Develop quality metrics, KPIs, and reporting processes.
• Drive a culture of continuous improvement across the business.
• Ensure systems remain scalable as the organisation grows towards late‑stage development and commercial readiness.

Experience & Qualifications

• Degree in Life Sciences, Pharmacy, Biotechnology, Quality, or a related scientific discipline.
• Significant experience within QA positions across biotechnology, advanced therapies, pharmaceuticals, or CRO environments.
• Strong knowledge of GCP and sponsor‑side clinical quality requirements.
• Experience establishing, implementing, or significantly improving quality systems and processes.
• Proven experience supporting CTAs, clinical development programmes, and regulatory submissions.
• Experience managing quality oversight of outsourced vendors, CROs, and CDMOs.
• Strong understanding of risk‑based quality management approaches.
• Excellent stakeholder management and influencing abilities.
• Comfortable operating within a highly entrepreneurial, fast‑paced environment.

Highly Desirable

• Gene therapy, cell therapy, ATMP, biologics, or viral vector experience.
• Experience supporting AAV programmes from development through clinical stages.
• Previous experience as the first QA hire or building a Quality function in a growing biotech.
• Regulatory inspection and audit experience.
• Knowledge of EU, UK, and US regulatory frameworks.
• Experience supporting clinical‑stage biotechnology organisations.

Why Join?

• Opportunity to become the first Quality leader within a cutting‑edge biotech.
• Shape and build the Quality function from day one.
• Work at the forefront of AAV‑based gene therapy development.
• Partner directly with senior leadership and influence business strategy.
• Join a well‑funded and ambitious organisation during a critical phase of growth.
• Highly visible role with significant scope for progression as the company expands.

This role will suit an experienced QA professional who enjoys building processes, influencing stakeholders, and taking ownership. The environment is dynamic, collaborative, and constantly evolving, therefore candidates must be comfortable working with ambiguity and able to balance strategic thinking with hands‑on execution.

For more information, please contact [e-mail]