Senior QA Manager

This is a fully remote position, open to applicants in Slovakia.

📋 Description

• Directs global process quality oversight activities by tracking, analyzing, and assessing escalations, quality events, audit/inspection results, and other quality indicators to pinpoint potential systemic process failures.

• Collaborates with functional and operational teams to establish, execute, and verify effective corrective and preventive actions through comprehensive management of global process CAPAs, fostering sustainable process enhancement and inspection-ready quality governance.

• Supervise, analyze, and trend escalations, quality events, audit and inspection outcomes, process deviations, and other quality indicators to detect recurring patterns, emerging risks, and potential systemic process failures.

• Lead the evaluation of whether identified trends signify isolated issues, functional deficiencies, or broader global process vulnerabilities requiring formal remediation.

• Own or assist with global process CAPAs from initiation to closure, including the development of problem statements, root cause analysis, action planning, effectiveness measures, evidence review, and timely completion.

• Ensure that CAPA actions are appropriately defined, feasible, defensible for inspections, and in alignment with relevant controlled documents, regulatory expectations, and business process ownership.

• Maintain oversight of global process CAPA status, risks, dependencies, and overdue or at-risk actions, escalating matters appropriately to RCQA and functional leadership.

• Generate and disseminate quality insights, trend analyses, and process risk information to support management reviews, governance forums, and prioritization of process improvement initiatives.

• Facilitate discussions across functions to align on process deficiencies, ownership, action plans, implementation timelines, and objective closure evidence.

• Utilize data analysis and quality intelligence to propose targeted process enhancements that boost process efficiency, minimize recurring issues, and bolster quality oversight across RCQA and operational processes.

• Serve as a process quality partner to operations and enabling functions, fostering a proactive culture of escalation, issue management, root cause analysis, and sustainable corrective actions.

• Assist in preparations for audits, inspections, sponsor inquiries, and internal governance discussions by ensuring that process CAPA rationale, evidence, and effectiveness documentation are clear, complete, and defensible.

• Contribute to global process governance forums by offering escalation trend analyses, insights into systemic issues, CAPA progress updates, and recommendations for prioritization.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Quality, Regulatory Affairs, or a related field preferred, or equivalent relevant experience.

• Typically, 8 or more years of experience in regulated clinical research, GxP, quality assurance, regulatory compliance, process governance, or a similar environment.

• Proven experience with quality systems, CAPA management, root cause analysis, issue management, escalation handling, and/or process improvement within a regulated context.

• Strong understanding of relevant GxP regulations, quality standards, and expectations for inspection-ready documentation.

• Ability to analyze quality data, escalation patterns, and recurring issue trends to identify potential systemic process failures and propose suitable remediation actions.

• Demonstrated ability to collaborate, influence, and negotiate with cross-functional stakeholders to achieve timely and sustainable process improvements.

• Capability 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.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development

• Bonuses