Senior Manager, Quality Assurance

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Job Responsibilities for the Senior Manager, Quality Assurance: 

• Develop, implement and maintain quality oversight plans, tools and templates
• Leads the implementation of client specific quality oversight plans for assigned clients, projects and/or portfolios.
• Ensures the quality oversight plan is completed according to internal requirements and agreed upon client expectations
• Liaises with project team leads (e.g. PM, CTM, etc.) on identified quality issues, quality/compliance trends, and works within the team to address and mitigate identified risks.
• Advises project team on global GCP regulations and guidance documents governing clinical trial development and serves as expert consultant to project teams and client representatives
• Oversees the development and finalization of all audit finding responses. Includes an assessment of completeness, compliance with GCP and PRA standards, and adequacy of response.
• Facilitates personally and/or ensures facilitation of all project, client and/or portfolio related quality issues (e.g.CAPAs) and ensures effectiveness checks are instituted in a timely manner
• Develops and delivers training on lessons learned through Audits and Inspections
• Leads the evaluation and management of site specific escalations related to persistent or serious misconduct.
• Participates, as requested, on quality related projects initiated by internal stakeholders
• Provides reports on quality trends, observations and suggestions to Management
• Liaises with the QA department in relation to inspection support requests and client audits, as appropriate
• Performs risk assessments and root cause analyses as needed
• Develops and implements client specific quality oversight program(s). This will include, but may not be limited to:
• Creating and delivering a comprehensive, global quality oversight plan in compliance with company SOPs (Standard Operating Procedures), GCP and clinical trials regulations.
• Provides expertise and guidance on global GCP topics, identifies compliance and quality trends and areas of potential compliance risk, proposes resolutions, oversees implementation of resolutions, and ensures effectiveness of solutions.
• Collaborates with internal functional areas to help maintain PRA’s high quality standards of clinical trial development.
• Qualifications for the Quality Oversight Manager: 
• An undergraduate degree or its international equivalent from an accredited institution required. Preferably in the health-sciences or computer sciences.
• 5+ years of clinical trial experience with GCP audit experience preferred.
• Must be willing to travel up to 25%
• Experience leading cross functional teams.
• Must have thorough understanding of ICH GCP, EU and US clinical trial regulations
• Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies and clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
• Read, write and speak fluent English; Fluency in other languages is a plus.
• Managerial experience in clinical research preferred
• Knowledge of CRO / Healthcare / Pharmaceutical quality assurance activities preferred
• Advanced degree preferred

#LI-MO1

#LI-Remote

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.