Quality ICM Senior Issue Lead

Quality ICM Senior Issue Lead - Audit - US or Canada

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Senior Issue Lead will be accountable for

• Quality Events: managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis. The Senior Issue Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. The Senior Issue Management Lead will direct the QE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required. The Senior Issue Lead will be assigned to and manage Critical and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team (QRT)

• Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation. Major areas of focus will include:

  • Audit coordination for GCP related process and preferred CRO vendor audits

  • CAPA management

  • Directing Inspection readiness and providing inspection support for GCP sponsor inspection activities

What You Will Do:

• Quality Event Investigation: Ensure that each confirmed case is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case to enable a meaningful investigation with appropriate quality outcomes which includes a case summary which meets defined quality standards and can be used for a regulatory inspection. The Senior Issue Lead will perform quality review and approval of select quality events which have been managed by other investigation leads. He/she will be assigned to process improvement initiatives and special projects as necessary and be expected to drive changes to the business process for case management when the need arises.

• Training and Technology: mentor and train Issue Leads to ensure the individuals reviewing the submitted issues are qualified to assess and categorize the submitted Quality Events.

• Root Cause Analysis: required to apply a root cause methodology and/or due diligence approach to assigned QEs. This individual may either lead QE cases from start to finish

• Quality Compliance Assessment: Plan, lead and report out on Quality and Compliance Assessments related to CD&O processes

• Audit and Inspection Coordination: may be assigned additional focus areas in audit coordination or inspection coordination, including inspection responsibilities around:

• Directing asset/study team colleagues within CD&O/Clinical to ensure successful inspection and audit outcomes

• Communicating audit and inspection progress and needs to CS&O/Clinical stakeholders

• Serving as the point of contact for Regulatory Quality Assurance related to audit and inspection CAPA management

Your Profile:

• 10+ years’ experience or equivalent with BS or 9+ years’ experience or equivalent with MBA/MS

• Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory

• Regulatory inspection experience

• Process and system management experience

• Detailed knowledge of clinical trial processes and relationships required

• Knowledge of GCP requirements and applicable SOPs and regulations

• Project management, administrative, and technical capabilities are required, as well as effective verbal and

• Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply