QA Director: Inspection-Ready Gene Therapy

Spur Therapeutics Limited; Stevenage; On-site; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Job summary

Spur Therapeutics Limited in Stevenage seeks a Director, Quality Assurance to lead the QA organization, ensuring cGMP compliance and readiness for global regulatory inspections. The role requires strategic governance and hands-on participation across manufacturing, analytical, and regulatory activities.

Ideal candidates will have 12+ years in QA within pharma/biotech, experience with external CDMOs, and a track record of successful regulatory interactions and product approvals in gene therapy or

Qualifications

• Minimum 12 years of progressively responsible QA experience in pharma/biotech/gene therapy.
• Experience leading QA within a GxP-regulated organization.
• Strong knowledge of FDA cGMP and EU GMP requirements.
• Experience with external CDMOs and contract testing labs.
• Ability to prepare for FDA inspections and mock inspections.

Responsibilities

• Provide leadership for the QA organization and set priorities.
• Ensure roles and decision rights across QA functions.
• Guide cross-functional teams on quality, regulatory, and operations.
• Lead inspection readiness activities and regulator communications.
• Oversee PPQ, validation, stability, and related regulatory work.
• Mentor QA personnel and establish objectives aligned with priorities.

Skills

Quality Assurance

GxP Knowledge

Regulatory Inspections

Leadership

Cross-functional Leadership

Risk Management

Data Integrity

CAPA

cGMP

Deviations & Change Controls

Education

Bachelor’s degree in biology/chemistry/biochemistry/engineering/pharmaceutical sciences

Advanced degree preferred

Tools

eQMS

Regulatory submission tools

Job description

Spur Therapeutics Limited in Stevenage seeks a Director, Quality Assurance to lead the QA organization, ensuring cGMP compliance and readiness for global regulatory inspections. The role requires strategic governance and hands-on participation across manufacturing, analytical, and regulatory activities.

Ideal candidates will have 12+ years in QA within pharma/biotech, experience with external CDMOs, and a track record of successful regulatory interactions and product approvals in gene therapy or