Job Overview:
Leads global process quality oversight activities by monitoring, trending, and evaluating escalations, quality events, audit/inspection outcomes, and other quality signals to identify potential systemic process failures. Partners with functional and operational teams to define, implement, and verify effective corrective and preventive actions through end-to-end management of global process CAPAs, supporting sustainable process improvement and inspection-ready quality governance.
Summary of Responsibilities:
• Monitor, review, and trend escalations, quality events, audit and inspection findings, process deviations, and other quality signals to identify recurring themes, emerging risks, and potential systemic process failures.
• Lead assessment of whether identified trends represent isolated issues, functional gaps, or broader global process weaknesses requiring formal remediation.
• Partner with process owners, operational leaders, RCQA stakeholders, and other cross-functional teams to define risk-based actions that address process gaps and prevent recurrence.
• Own or support global process CAPAs from initiation through closure, including problem statement development, root cause evaluation, action planning, effectiveness measures, evidence review, and timely completion.
• Ensure CAPA actions are appropriately scoped, achievable, inspection-defensible, and aligned with applicable controlled documents, regulatory expectations, and business process ownership.
• Maintain visibility of global process CAPA status, risks, dependencies, and overdue or at-risk actions, escalating appropriately to RCQA and functional leadership.
• Develop and communicate quality insights, trend summaries, and process risk information to support management review, governance forums, and prioritization of process improvement activities.
• Facilitate cross-functional discussions to align on process gaps, ownership, action plans, implementation timelines, and objective closure evidence.
• Use data analysis and quality intelligence to recommend targeted process improvements that increase process effectiveness, reduce repeat issues, and strengthen quality oversight across RCQA and operational processes.
• Act as a process quality partner to operations and enabling functions, promoting a proactive culture of escalation, issue management, root cause thinking, and sustainable corrective action.
• Support preparation for audits, inspections, sponsor inquiries, and internal governance discussions by ensuring process CAPA rationale, evidence, and effectiveness documentation are clear, complete, and defensible.
• Contribute to global process governance forums by providing escalation trend analysis, systemic issue insights, CAPA progress updates, and recommendations for prioritization.
• Perform other duties as needed or assigned.
Qualifications (Minimum Required):
• Bachelor’s degree in Life Sciences, Quality, Regulatory Affairs, or related discipline preferred, or equivalent relevant experience.
• Experience may be substituted for education.
Experience (Minimum Required):
• Typically, 8 or more years of experience in regulated clinical research, GxP, quality assurance, regulatory compliance, process governance, or related environment.
• Demonstrated experience with quality systems, CAPA management, root cause analysis, issue management, escalation handling, and/or process improvement in a regulated environment.
• Strong understanding of applicable GxP regulations, quality standards, and expectations for inspection-ready documentation.
• Ability to analyze quality data, escalation trends, and recurring issue patterns to identify potential systemic process failures and recommend appropriate remediation.
• Proven ability to collaborate, influence, and negotiate with cross-functional stakeholders to achieve timely and sustainable process improvements.
• Ability to distill complex quality information into clear conclusions, risk-based recommendations, and management-level communications.
• Ability to lead or coordinate cross-functional teams through CAPA development, implementation, effectiveness verification, and closure.
• Experience preparing governance updates, quality summaries, or process risk communications for leadership forums preferred.
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