Manager, Validation

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 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
• Rationalise validation documentation (and protocol requirements) to ease routine validation activities while validation requirements are met
• Liaise 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 brief Kent Operations personnel as appropriate
• Attend meetings, both internal and external, representing the department in a professional manner
• Ensure review and update of validation procedures (Policies, Master plans, Standard Operating Procedures (SOP's) etc.) for equipment and facilities
• Participate 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 validationand GMP related experience.

The successful candidate should have

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

At SEKISUI Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. 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. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.

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. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.