Quality Lead for Regenerative Medicine CDMO (MHRA-ready)

Cytera CellWorks; Stevenage; On-site; GBP 125,000 - 150,000; Full time

Job summary

A pioneering regenerative medicine company in Stevenage is looking for a Quality Assurance Lead to drive regulatory compliance and quality strategy. You will oversee the establishment of quality systems necessary for obtaining the MHRA Manufacturing and Import Authorisation license. The ideal candidate has significant QA experience and a strong understanding of MHRA regulations. This role offers a competitive salary with stock options and a collaborative environment focused on continuous improvement.

Benefits

Competitive salary with stock options

Lunch covered daily

24 days holiday

Pension

Qualifications

• Significant QA experience in a GxP environment, ideally in ATMPs, biologics, or cell therapy.
• Strong understanding of MHRA and EU GMP, with hands-on experience preparing for inspections.
• Experience with document control, deviations, CAPA, change control, and validation.

Responsibilities

• Lead Mytos to an MHRA MIA (IMP) license for our first site.
• Establish and maintain a robust and scalable PQS.
• Manage compliance with quality policies and procedures.

Skills

QA experience (>5 years)

Knowledge of MHRA and EU GMP

Excellent written and verbal communication skills

Experience with PQS systems

Job description

A pioneering regenerative medicine company in Stevenage is looking for a Quality Assurance Lead to drive regulatory compliance and quality strategy. You will oversee the establishment of quality systems necessary for obtaining the MHRA Manufacturing and Import Authorisation license. The ideal candidate has significant QA experience and a strong understanding of MHRA regulations. This role offers a competitive salary with stock options and a collaborative environment focused on continuous improvement.