Quality Assurance Manager

3 weeks ago


Stevenage, United Kingdom Albion Rye Associates Full time

Position: Quality Assurance Manager

Location: Stevenage


We are working with a dynamic and innovative small to medium-sized Biotech looking for a QA Manager (GCP) to join their team. Their passionate team of scientists, clinicians, and professionals are committed to translating scientific discoveries into life-changing therapies for patients worldwide.


Key Responsibilities:

  • Develop and uphold GCP/ICH compliant processes to oversee the quality of clinical trials.
  • Support internal audits, CAPA, and quality management reviews.
  • Collaborate with the Head of QA during regulatory agency and client audits.
  • Identify non-conformances, offer recommendations, and drive quality improvements.
  • Conduct vendor audits and foster continuous improvement in service delivery.
  • Facilitate training for our clinical staff and manage our eQMS system effectively.
  • Keep abreast of quality legislation and compliance issues, ensuring adherence to standards.


Required Skills & Qualifications:

  • Bachelor's degree in Life Science or related field.
  • Minimum 3 years of CQA experience in a regulated industry.
  • Proficiency in ICH/FDA GCP guidelines with practical knowledge.
  • Familiarity with risk-based quality systems consistent with ICH E-6.
  • Experience in FDA/EMA inspections and customer audits.
  • Strong communication, attention to detail, and time management skills.
  • Demonstrated work ethic and commitment to quality.


If you are looking for an opportunity that challenges you whilst supporting you in your career.... apply or drop me a call



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