Quality Assurance Team Leader

TN United Kingdom; Guildford; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading company in Guildford is seeking a Quality Assurance Team Leader to oversee QA functions in IMP manufacturing. The role demands strong leadership and compliance with GMP and GCP standards, ensuring quality oversight and documentation. The successful candidate will manage a small team and maintain the Quality Management System, while interfacing with cross-functional teams to ensure compliance with clinical trial regulations.

Qualifications

• Experience in leading QA teams and functions.
• Strong knowledge of GMP, GCP, and regulatory requirements.

Responsibilities

• Oversee day-to-day QA activities associated with IMP manufacturing.
• Lead internal audits and support external audits for compliance.
• Maintain and improve the Quality Management System.

Skills

Leadership

Attention to Detail

Quality Assurance

Job description

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Quality Assurance Team Leader, Guildford

Client: MedPharm

Location: Guildford, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 9f3e5b279cdd

Job Views: 4

Posted: 12.05.2025

Expiry Date: 26.06.2025

Job Description:

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

1. Oversee day-to-day QA activities associated with IMP manufacturing.
2. Provide quality oversight for batch record review, line clearances, and approval of manufacturing and packaging documentation.
3. Review and approve deviations, CAPAs, change controls, OOS/OOT, and audit observations.
4. Lead internal audits and support external and regulatory audits to ensure compliance with GxP (GMP and GLP) and other applicable standards.
5. Approve or reject starting materials, packaging components, and finished products.
6. Maintain and continuously improve the Quality Management System (QMS).
7. Maintain current regulatory knowledge, communicating information and updates to staff as appropriate.
8. Review and issue SOPs and QA-related documentation in the electronic QMS.
9. Ensure proper QA documentation is archived in line with GLP/GMP expectations.
10. Support training and implementation of GxP-compliant procedures.
11. Audit raw data (and associated study documentation where appropriate) to ensure that the work has been completed to GxP standards.
12. Interface with cross-functional teams including Manufacturing, QC, Project Management, Regulatory Affairs, and Supply Chain.
13. Ensure compliance with clinical trial regulations and IMP labelling and documentation requirements.
14. 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.