Senior Validation & GMP Compliance Lead

Sekisui Diagnostics, LLC; Maidstone; On-site; GBP 85,000 - 110,000; Full time

Job summary

SEKISUI Diagnostics is seeking a dedicated QA Validation Manager to lead the validation function within our Quality Assurance team. This full-time role reports to the Head of Quality and drives cGMP compliance across facilities, equipment and processes.

You will design and execute validation protocols, mentor staff, and ensure timely, well-documented validation activities while staying current with regulatory changes such as EudraLex.

Qualifications

• Typically requires a scientific university degree and a minimum of 10 years of validation and GMP experience.
• Strong knowledge of EudraLex Volume 4 and Annex 11 & 15.
• Experience in managing people and leading validation activities.

Responsibilities

• Coordinate and perform validation activities for facilities, equipment, and processes.
• Prepare, execute and report validation protocols.
• Maintain validation documentation and SOPs.
• Liaise with Engineering and QA to ensure timely validation with minimal production disruption.
• Support audits by customers and regulatory authorities.

Skills

Leadership

Validation expertise

GMP knowledge

Education

Scientific university degree

Job description

SEKISUI Diagnostics is seeking a dedicated QA Validation Manager to lead the validation function within our Quality Assurance team. This full-time role reports to the Head of Quality and drives cGMP compliance across facilities, equipment and processes.

You will design and execute validation protocols, mentor staff, and ensure timely, well-documented validation activities while staying current with regulatory changes such as EudraLex.