Senior Manager, Quality Assurance at ICON plc

Responsibilities:

• Recognize, exemplify and adhere to ICON's values which center on Integrity, Accountability & Delivery, Collaboration, Partnership and Own IT@ICON
• Manage Projects, People and/or Audits relevant to the Functional area as appropriate for the position.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a Manager, the employee is expected to recognize the importance of and create a  culture  of process  improvement  with  a  focus  on  streamlining  our  processes  adding  value  to  our  business and meeting client needs.
• Identify changes and be aware of pending changes to GXP industry regulations and guidance’s worldwide.
• Acquire full awareness of sponsor’s book of work, client requirements, SOPs, deliverables, KQIs, KPIs and frequency of reporting.
• Support Review of all client-specific processes and documentation to ensure relevance to current agreements with the client as well as adherence to the processes outlined.
• Facilitates 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.
• Support preparation and management of audits and inspections providing expertise and guidance to gain successful outcomes.
• Drive special projects surrounding Quality or Operations updates that require change management, client communication, and/or process updates.
• Review client related metrics, including assisting in metric collection as needed; investigate and troubleshoot quality issues from internally or externally driven complaints and/or client audits.
• Present at internal and external meetings, including analysis and presentation of Quality data, and respond to questions / requests as applicable.
• Attend Governance level meetings at the required frequency, participate in discussions and/or present quality topics and/or quality data.
• Act in a proactive, flexible and responsive manner to customer needs; communicate with clarity of purposes, setting clear direction.
• Provide innovation or enhancement to existing client relationships – this can include initiating forums to engage internal program teams on quality metrics/trends for their programs, implementing lessons learned for audits or inspection outcomes, partner with client on portfolio level initiatives.
• Advocate for the client with all internal departments to drive process improvement in all relevant areas.
• Proactively identify actions and areas for improvement at the portfolio/ Customer level.
• Provide technical/SME guidance to employees/colleagues and/or customers.
• Actively participate in or lead process improvement initiatives with the Q&C teams/ICON teams and ensure achievement of high-quality standards.
• Identifies and resolves technical and/or operational issues, drawing on company policies and guidelines and identifying exceptions for further review.
• To undertake other reasonably related duties as may be assigned from time to time.

Requirements:

• At least 3-5 years of QA experience in a GCP environment
• Strong stakeholder management skills and proven experience in a sponsor-facing role