Quality Assurance Manager (Contract, GCP)

Job Title:Quality Assurance Manager

Location:London, UK

Type:6-12 month Contract, Full-time, Hybrid (1 day in office p/w)

About the Job

We are collaborating with a dynamic organization in the clinical development sector to identify a skilled Manager of Quality Assurance. This critical role is essential to ensuring compliance with global quality standards, maintaining excellence in quality systems, and driving audit readiness and inspection outcomes. A key focus of this role is on Good Clinical Practice (GCP) compliance, so candidates must have significant prior experience in GCP, with less emphasis on other GxP areas.

About the Role

As a Manager of Quality Assurance, you will play a pivotal role in maintaining the Quality Management System (QMS), overseeing audit activities, and supporting quality training initiatives. This position involves partnering with cross-functional teams and external stakeholders to ensure adherence to GCP and regulatory requirements.

Key Responsibilities:

Quality Systems Oversight:

• Manage and update QMS documents, including SOPs, policies, and templates, ensuring compliance with GCP and global regulations.
• Track and address deviations, implement corrective actions, and maintain quality logs.

Audit Coordination and Support:

• Schedule, coordinate, and track audits (internal and external) with a focus on GCP compliance, ensuring findings are resolved efficiently.
• Review audit reports, oversee corrective and preventative actions (CAPAs), and ensure documentation integrity.

Inspection Readiness and Compliance:

• Prepare teams for regulatory inspections, providing training and site support as needed, particularly for GCP-related requirements.
• Address inspection findings with timely and appropriate responses.

Training and Advisory:

• Deliver foundational training on quality and regulatory topics to staff, with emphasis on GCP principles.
• Provide quality-related guidance to project teams, fostering a culture of compliance.

Your Profile

• Bachelor’s degree in life sciences or a related field.
• At least 5 years of experience in quality assurance within the clinical or pharmaceutical industry, with the majority of this experience focused on GCP.
• Strong understanding of GCP and global regulatory requirements.
• Excellent organizational skills, with the ability to manage multiple priorities.
• Effective communicator with the ability to influence and collaborate across teams.

This role is well-suited to candidates with substantial GCP expertise and a strong commitment to ensuring compliance in clinical development.