QA Validation Lead - GMP / Regulatory Compliance

Sekisui Diagnostics, LLC; United Kingdom; Remote; GBP 70,000 - 110,000; Full time

Job summary

SEKISUI Diagnostics is seeking a dedicated QA Validation Manager to lead a high-performing QA team in the UK. This role focuses on designing, executing, and continuously improving validation systems and processes in line with cGMP requirements.

The successful candidate will recruit and mentor staff, ensure robust validation programs, and drive continuous improvement. Reporting to the Head of Quality, you will coordinate cross-functional efforts and participate in audits to uphold regulatory

Qualifications

• Requires a scientific university degree and extensive validation/GMP experience.
• Proven ability to lead and develop a high-performing team.

Responsibilities

• Coordinate validation activities for facilities, equipment and processes in GMP scope.
• Develop and implement best practices and SOPs for validation.
• Provide direction and expertise in validation management and reporting.
• Prepare, execute and report validation protocols and documentation.
• Liaise with Engineering, QA and other departments to ensure timely validation.
• Monitor regulatory developments and brief operations on changes.
• Attend internal and external audits representing the department.

Skills

QA Validation

Leadership

GMP

Mentoring

Regulatory Knowledge

Project Management

Education

Scientific degree

Job description

SEKISUI Diagnostics is seeking a dedicated QA Validation Manager to lead a high-performing QA team in the UK. This role focuses on designing, executing, and continuously improving validation systems and processes in line with cGMP requirements.

The successful candidate will recruit and mentor staff, ensure robust validation programs, and drive continuous improvement. Reporting to the Head of Quality, you will coordinate cross-functional efforts and participate in audits to uphold regulatory