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📞
📞 020 8150 5658
✉️ megan.siggins@albionryeassociates.com