Senior Quality Manager (Inspection Readiness) - Home-Based

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

POSITION SUMMARY:

The Senior Quality Manager will manage inspection readiness activities across Outsourcing, including audit preparation and support.  The Senior Quality Manager will provide leadership support to the OS quality team members and Head, OS Quality.  This role will work closely with the OS Leadership team to share quality trend analysis and own the mitigation plan to address gap areas.  This role will also support VBM- level inspection readiness activities in areas where cross-functional coordination, standardization or oversight is required.

As required, the Senior Quality Manger will provide senior-level QC review of OS contracts and assure adherence to Outsourcing processes.

• OS Inspection Readiness:
• Develop and maintain  Outsourcing  process  documentation (e.g.,  SOP,  WI,  job  aids, contract templates, OS team files/shared drive)
• Oversight of VCT audit process
• Primary POC for audit requests
• Responsible for OS documentation in support of an audit
• Participate in/support audit meetings
• Support OS team in preparation for audit
• Maintain audit calendar and share upcoming dates with OSLT
• OS Quality Best Practices:
• Perform analysis to identify trends related to quality and inspection readiness
• Create and oversee mitigation plan to address any gap areas
• Lead training sessions for OS team
• Ensure OS job aids and processes are kept up to date
• Partner closely with Quality counterparts in CQM and Quality to ensure OS has robust processes in place to support future audits.
• Collaborate with Head, OS Quality and VBM Quality SMEs on cross-functional VBM inspection readiness activities and initiatives
• OS QC Review:
• Provide senior-level QC review of clinical, non-clinical, and healthcare practitioner (HCP) contracts created by Outsourcing managers, including formatting, content, logic, and budget.  Review of contracting database entries associated with contract under review.
• Other duties as required.

INTERPERSONAL AND TECHNICAL SKILLS

• Excellent communication skills; able to engage team members at all levels
• Ability to work cross-functionally
• Able to gain consensus across stakeholders
• Demonstrated negotiation and conflict resolution skills
• Ability to distill information into concise written documentation
• Attention to detail
• Ability to handle multiple priorities within matrix environment

PREFERRED EDUCATION AND EXPERIENCE LEVELS:

• Bachelor's degree is required, master’s degree a plus
• Minimum of 8-10 years of experience at a CRO or sponsor
• High degree of experience in quality management, including inspection readiness oversight, audit preparation and participation
• Previous experience with process development (SOP, WI) desired
• High degree of experience in outsourcing/contract management
• Ability to critically review clinical contracts and budgets using the master agreement, rate cards, and established commercial terms
• High level of proficiency in Word, Excel, Outlook, and Teams
• Familiarity with standard videoconferencing tools

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.