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Manager, Scientific Affairs

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ICON plc

11d ago

  • Job
    Full-time
    Expert Level
  • Research & Development
    Healthcare
  • Dublin
  • Quick Apply

AI generated summary

  • You need a Bachelor’s in Clinical Lab Science or related field, 10+ years in clinical lab testing, 3+ years in leadership, expertise in validation, and strong communication skills.
  • You will lead diagnostic test validations, ensure regulatory compliance, mentor analysts, coordinate with cross-functional teams, and prepare documentation for submissions and inspections.

Requirements

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

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

FAQs

What is the job title for this position?

The job title for this position is Senior Manager, Laboratory Quality Control.

Where is the job located?

The job is located in Dublin, Ireland, and follows a hybrid work model, combining office and remote work.

What are the key responsibilities of this role?

Key responsibilities include leading and managing the validation and verification of diagnostic tests, designing and analyzing validation experiments, supervising a team of Global Validation Analysts, and collaborating with various internal and external stakeholders.

What qualifications are required for this position?

Candidates should have a Bachelor’s degree in Clinical Laboratory Science, Biomedical Science, or a related field, with an advanced degree preferred. Additionally, a minimum of 10 years of experience in clinical laboratory testing and at least 3 years in a management role focused on test validations is required.

What skills are necessary for this role?

Necessary skills include strong knowledge of validation methodologies, quality assurance principles, and regulatory requirements, excellent leadership and team management abilities, proficiency in data analysis, and exceptional communication and interpersonal skills.

Will there be opportunities for training and development?

Yes, the role involves providing training and support to team members on validation techniques and best practices, as well as identifying and implementing necessary training programs.

How does ICON support employee well-being?

ICON offers various benefits focused on employee well-being, including health insurance offerings, retirement planning options, and access to a global Employee Assistance Programme.

Is this position management-focused?

Yes, this position is management-focused, as it involves supervising and mentoring a team of Global Validation Analysts and fostering a high-performance work environment.

What type of experience is preferred for this role?

Preferred experience includes clinical laboratory testing, particularly in validation and verification processes, and familiarity with EP evaluator software.

What is the company culture like at ICON?

ICON fosters an inclusive environment that promotes innovation and excellence, emphasizing key values such as Accountability & Delivery, Collaboration, Partnership, and Integrity.

ICON plc

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.