Manager, Scientific Affairs - Test Validation

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The role manages, oversees and leads Test Validations, implementing new assays across 4 clinical laboratories globally. This role will support multiple platforms and departments including Clinical Chemistry, Hematology, Special Chemistry, Immunology, Pathology, Molecular Biology, and Molecular Diagnostics. The applicant is not required to be an subject matter expert in all these disciplines but should be knowledgeable enough to communicate across disciplines. This role approves performance of analytical validations within ICON Laboratory Services including the review of assay product inserts, preparation of validation plans, identification and attainment of suitable samples for validation studies, the performance of validation experiments, analysis and quality control of data and the preparation of validation reports.  

This pivotal role involves ensuring that all diagnostic tests and procedures meet the highest standards of accuracy, reliability, and compliance. The ideal candidate will have extensive experience in clinical laboratory testing, a strong background in quality assurance, and proven leadership abilities. This role is office based (hybrid working) at our global HR in Dublin 18.

Key Responsibilities: 

Lead and manage the validation and verification of diagnostic tests, including new assays and instruments 

Design, perform, and analyse Accuracy, Precision, Reference Range, AMR and other standard validation / verification experiments 

Manage the validation of complex and Lab Developed tests including modifications to existing tests. 

Work directly with Sponsors on Sponsor-specific validations and requirements 

Ensure that all validation processes comply with regulatory requirements, industry standards, and internal quality guidelines while following and maintaining Global SOPs. 

Conduct regular assessments of validation practices to identify areas for improvement. 

Perform root cause analysis on quality issues and suggest corrective and preventive actions. 

Supervise and mentor a team of Global Validation Analysts 

Provide training and support to team members on validation techniques and best practices. 

Foster a collaborative and high-performance work environment. 

Identify and implement training programs as necessary to ensure they receive training in supervisory skill development 

Productively work with internal groups such as Regulatory Affairs, Medical Affairs, Clinical Research, Project Management, and/or Quality Assurance to ensure efficient operations across the organization  

Work closely with cross-functional teams including Laboratory operations, Global Quality Control, and Regulatory Affairs. 

Liaise with global laboratories to coordinate validation activities and share best practices. 

Keep management informed of project status in relation to quality and timelines using the validations tracker. 

Independently provides additional medical communications writing and editing services as required (for example for manuscripts, abstracts and scientific posters). 

Stay current with changes in regulatory requirements and ensure that validation processes are updated accordingly. 

Prepare and present documentation for regulatory submissions and inspections in collaboration with Regulatory Affairs. 

Maintain accurate and thorough documentation of all validation activities. 

Prepare comprehensive reports for internal stakeholders and regulatory bodies. 

Exhibit excellent written and oral communication and presentation skills. Is able to collaborate well at a complex level.  

What you need:

• Education: Bachelor’s degree in Clinical Laboratory Science, Biomedical Science, or a related field; advanced degree preferred.

•  Minimum of 10 years of experience in clinical laboratory testing, with at least 3 years in a management or leadership role focused on test validations. 

• Experience in EP evaluator software, preferable 

• Strong knowledge of validation methodologies, quality assurance principles, and regulatory requirements (e.g., CAP, NYS, CLSI, FDA, ISO, CLIA). 

• Excellent leadership and team management skills. 

• Proficiency in data analysis and interpretation. 

• Exceptional communication and interpersonal skills. 

• Ability to work effectively in a global and cross-functional environment.

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