QA Team Lead

We are currently looking for a QA Team Leader to join a leading Gene Therapy company based in London. As the QA Team Leader, you will be responsible for leading, supervising, managing and training the Quality Systems team and continuously improving the local Quality Systems.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the QA Team Leader will be varied. However, the key duties and responsibilities are as follows:

1. You will implement and manage the Quality Management System, assuring Compliance to MHRA and FDA regulations; manage and oversee the GMP document management and document control process through full lifecycle.

2. As the QA Team Leader, you will manage the Quality Systems team and have a full oversight of the hiring and on-boarding process, through to coaching and mentoring, setting team objectives, managing the team performance and the development of staff.

3. You will ensure Audit Readiness and coordinate preparations for Regulatory Inspections; oversee and review Quality Risk Management, Deviations and their investigations; and ensure implementation of appropriate CAPAs and Change Controls, whilst ensuring they are monitored through to closure.

4. As the QA Team Leader, you will ensure the Quality Systems team works to Good Manufacturing Practice, Good Documentation Practice and Data Integrity Compliance.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the QA Team Leader we are looking to identify the following on your profile and past history:

1. Relevant Life Sciences degree.

2. Proven industry experience in leading a QA team.

3. A working knowledge and practical experience within a Sterile GMP manufacturing environment.


Key Words: QA | Quality Assurance | ATMP | Advanced Therapy Medicinal Product | Cell Therapy | Gene Therapy | Cell and Gene Therapy | QMS | Quality Management System | GMP | cGMP | Good Manufacturing Practice | GDocP | Good Documentation Practice | Data Integrity | MHRA | FDA | Compliance | Regulatory Inspections | Audit | QRM | Quality Risk Management | Deviation | CAPA | Change Control | Team Management | Training Staff

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.