Governance Quality Operations Lead

ICON plc • Blue Bell, SD

4d • Remote

About The Position

Governance Quality Operations Lead-Remote 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 GCP Quality Governance Operations Lead is responsible for providing strategic and operational expertise to drive the management (planning, execution and follow-up of GCP Quality governance forums, councils and committees. Serves as a liaison and SME for teams on the quality governance process and leads teams in planning and preparation for governance interactions. Manages the development and oversight of Metrics generation to support compliance and impact/trend analysis across governance reviews. Uses process experience and expertise to implement process workflow improvements and efficiencies and improvements in the process and documentation. Oversees quality governance tools, tracking and mechanisms Facilitates and oversees the annual governance charter review process What You Will Be Doing:

Requirements

• Bachelor’s Degree or equivalent experience a must
• 5+years of related pharmaceutical and/or quality experience
• A robust understanding of research and development and GCP
• Project or role-based experience in the following: policy and standards, process management and reporting, and change management/ adoption
• High energy and drive for organization and execution
• Excellent verbal and written communication skills; must be able to interact effectively with professionals at all levels and communicate recommendations with diplomacy and tact
• Strong project management skills, with experience managing time sensitive projects
• Ability to prioritize and demonstrates strong organizational skills and the ability to manage multiple tasks and projects simultaneously
• Advanced skills in all common O365 applications and other reporting tools
• Experience with project management, process tracking or other workflow tools

Responsibilities

• Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation.
• Plans, drafts, reviews and delivers outputs from quality governance forums including escalations, decisions, annual reports and other documentation as well as coordinate, prioritize and sequence quality governance topics.
• Directs GCP quality governance metrics and assessment of GCP quality governance effectiveness and efficiency.
• Collects and reports data to support assessment of compliance to process, trends, and common issues with a view towards overall impact and continuous improvement
• Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion.
• Execution and oversight of the periodic review of GCP quality governance forum remit, charter, scope, membership
• Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees