Quality Assurance Team Lead
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Location | London |
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Job Type | Permanent |
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Salary | £NEG |
Blackfield Associates is partnered with a Cell and Gene Therapy organization that is looking for a Quality Team Lead.
Responsibilities
As the QA Team Lead, you will be responsible for overseeing Quality Assurance operations within a GMP-regulated manufacturing environment. This role ensures compliance with regulatory requirements, facilitates product release, and provides QA oversight for manufacturing activities. The position involves managing a team, training staff, maintaining Quality Management Systems (QMS), and supporting audits and regulatory inspections. Other responsibilities include (but are not limited to):
- Manage and oversee QA Associates, ensuring workload distribution and compliance with GMP standards, while providing support for manufacturing operations to ensure product quality and regulatory compliance.
- Review, approve, and ensure compliance of GMP documentation (batch records, SOPs, CAPAs, deviations, and change controls) while conducting internal audits, inspections, and facility walkarounds.
- Support and train the QA team to continuously improve local Quality Systems, processes, and performance metrics, contributing to continuous improvement initiatives.
- Act as a key point of contact during regulatory inspections and customer audits, ensuring compliance with Good Documentation Practices (GDP), data integrity, and GMP guidelines.
Requirements
The ideal candidate will have a strong background in sterile GMP manufacturing, Quality Management Systems, and regulatory compliance as well as being skilled in risk management and continuous improvement initiatives. You will need to have proven ability to lead teams, conduct audits, and ensure compliance with regulatory standards. Over five years of experience in Quality Assurance within GxP-regulated environments.