General Information
Title: QA Team Lead
Date: 02 May 25
Site: Guildford, UK
FLSA Status (US Only): Exempt/Non-Exempt
Department: Quality Assurance
Reporting To: Director of Quality Assurance

POSITION SUMMARY

The QA Team Lead is responsible for leading the Quality Assurance function supporting Investigational Medicinal Product (IMP) manufacturing operations. This role ensures compliance with GMP, GCP, and regulatory requirements while managing a small team of QA professionals. The QA Team Lead plays a key role in maintaining and improving the site’s Quality Management System, ensuring quality oversight of manufacturing, documentation, investigations, and quality records.
This is a 100% on-site role requiring strong leadership, attention to detail, and hands-on QA support across all IMP production activities.

Essential Functions

• Oversee day-to-day QA activities associated with IMP manufacturing.
• Provide quality oversight for batch record review, line clearances, and approval of manufacturing and packaging documentation.
• Review and approve deviations, CAPAs, change controls, OOS/OOT, and audit observations.
• Lead internal audits and support external and regulatory audits to ensure compliance with GxP (GMP and GLP) and other applicable standards.
• Approve or reject starting materials, packaging components, and finished products.
• Maintain and continuously improve the Quality Management System (QMS).
• Maintain current regulatory knowledge, communicating information and updates to staff as appropriate.
• Review and issue SOPs and QA-related documentation in the electronic QMS.
• Ensure proper QA documentation is archived in line with GLP/GMP expectations.
• Support training and implementation of GxP-compliant procedures.
• Audit raw data (and associated study documentation where appropriate) to ensure that the work has been completed to GxP.
• Interface with cross-functional teams including Manufacturing, QC, Project Management, Regulatory Affairs, and Supply Chain.
• Ensure compliance with clinical trial regulations and IMP labelling and documentation requirements.
• Provide support for QP release preparation and documentation review.

Supervisory responsibilities:

• Line management of QA Officers.
• Provide mentoring, training, and performance management for direct reports.
• Act as delegate for the Director of QA during their absence.

Key Relationships:

• Production Teams
• Quality Control
• Project Management
• Clients and Auditors

Travel requirements:

• Occasional travel may be required for training or audit activities (<10%)

Education and Experience

• Bachelor’s degree in scientific or related discipline.
• Minimum 5 years of experience in a GMP-regulated QA environment.
• Experience in GMP manufacturing, batch release, and QMS management is essential.
• Prior experience in a QA leadership or supervisory capacity preferred.

Knowledge, Skills, and Abilities

• In-depth knowledge of GMP, GCP, and clinical trial regulations.
• Strong understanding of IMP requirements and QP release processes.
• Experienced in handling deviations, CAPAs, and change controls.
• Excellent written and verbal communication skills.
• Highly organised with strong attention to detail.
• Able to work effectively under pressure and manage multiple priorities.
• Proficient in electronic QMS and document management systems.
• Proactive, self-motivated, and team-oriented.

LIMITATIONS AND DISCLAIMER

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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OTHER DUTIES

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Essential Functions

• Oversee day-to-day QA activities associated with IMP manufacturing.
• Provide quality oversight for batch record review, line clearances, and approval of manufacturing and packaging documentation.
• Review and approve deviations, CAPAs, change controls, OOS/OOT, and audit observations.
• Lead internal audits and support external and regulatory audits to ensure compliance with GxP (GMP and GLP) and other applicable standards.
• Approve or reject starting materials, packaging components, and finished products.
• Maintain and continuously improve the Quality Management System (QMS).
• Maintain current regulatory knowledge, communicating information and updates to staff as appropriate.
• Review and issue SOPs and QA-related documentation in the electronic QMS.
• Ensure proper QA documentation is archived in line with GLP/GMP expectations.
• Support training and implementation of GxP-compliant procedures.
• Audit raw data (and associated study documentation where appropriate) to ensure that the work has been completed to GxP.
• Interface with cross-functional teams including Manufacturing, QC, Project Management, Regulatory Affairs, and Supply Chain.
• Ensure compliance with clinical trial regulations and IMP labelling and documentation requirements.
• Provide support for QP release preparation and documentation review

Supervisory responsibilities:

• Line management of QA Officers.
• Provide mentoring, training, and performance management for direct reports.
• Act as delegate for the Director of QA during their absence

While performing the duties of this job, there may be certain physical demands required for the position.

• Regularly required to walk within production and laboratory areas.
• May be required to stand for extended periods.
• Exposure to cleanroom environments and temperature-controlled zones