Manager, Validation in London

SEKISUI Diagnostics are looking to appoint a dedicated and experienced QA Validation Manager to join our Quality Assurance team on a full-time basis. This key position reports directly to the Head of Quality and plays a vital role in guiding a high-performing team committed to securing cGMP certification for the organisation.

The ideal candidate will be responsible for leading the design, execution, and continuous improvement of validation systems and processes. This includes recruiting and mentoring members to ensure optimal performance and operational excellence within the function.

The responsibilities for this role include, but are not limited to:

• Co-ordinating and performing validation project activities for all facilities, equipment and processes operated in compliance with EurdraLex Volume 4 – Good Manufacturing Practice (GMP) guideline requirements and other applicable quality system requirements.
• Establishing and maintaining best practices for departmental procedures to ensure effectiveness to validation requirements.
• Providing direction and expertise in the management of validation activities.
• Preparing, executing and reporting validation protocols.
• Rationalising validation documentation (and protocol requirements) to ease routine validation activities while validation requirements are met.
• Liaising with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner with minimal disruption to production.
• Maintaining an awareness of regulatory developments in the validation field and briefing Kent Operations personnel as appropriate.
• Attending meetings, both internal and external, representing the department in a professional manner.
• Ensuring review and update of validation procedures (Policies, Master plans, Standard Operating Procedures (SOP’s) etc.) for equipment and facilities.
• Participating in audits by customers and regulatory authorities.

This job is fully qualified, career-oriented, and journey-level position. Typically requires a scientific university degree and a minimum of 10 years of validation and GMP related experience.

The successful candidate should have:

• Specific knowledge of EudraLex Volume 4, including validation requirements in Annex 1, 11, 15 and Biopharmaceutical cleaning validation.
• Experience in managing people.
• Ability to author and execute validation reports.

If this sounds like you, please apply for immediate consideration.

At SEKISUI Diagnostics, we help improve patient outcomes by focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied.

SEKISUI Diagnostics offers a competitive compensation and benefits package. As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws.

SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.