Quality ICM Senior Issue Lead

ICON plc • Blue Bell, SD

9d

About The Position

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). 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.

Requirements

• 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.

Responsibilities

• 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.
• Perform quality review and approval of select quality events which have been managed by other investigation leads.
• 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.
• Mentor and train Issue Leads to ensure the individuals reviewing the submitted issues are qualified to assess and categorize the submitted Quality Events.
• Apply a root cause methodology and/or due diligence approach to assigned QEs.
• Lead QE cases from start to finish.
• Plan, lead and report out on Quality and Compliance Assessments related to CD&O processes.
• 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.

Benefits

• 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: Senior