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QA Senior Manager
Global Process Quality Manager
Job Overview
Leads global process quality oversight activities by:
- Monitoring, trending, and evaluating escalations, quality events, audit/inspection outcomes, and other quality signals
- Identifying potential systemic process failures
- Partnering with functional and operational teams to define, implement, and verify effective corrective and preventive actions (CAPAs)
- Supporting sustainable process improvement and inspection-ready quality governance
Key Responsibilities
- Monitor trends: Review escalations, quality events, audit/inspection findings, process deviations, and other quality signals to pinpoint recurring themes, risks, and systemic failures.
- Risk assessment: Determine whether identified trends are isolated or require formal global process remediation.
- Cross-functional collaboration:
- Partner with process owners, operational and RCQA stakeholders to define risk-based actions addressing process gaps
- Ensure CAPA timelines align with regulatory expectations and business needs
- End-to-end CAPA ownership:
- Develop problem statements, conduct root cause evaluations, and execute action plans
- Validate effectiveness, document evidence, and secure timely closure
- Impactful recommendations:
- Leverage data analytics and quality intelligence to propose targeted process improvements
- Strengthen compliance for audits, inspections, and governance discussions
- Proactive quality advocacy:
- Foster a culture of escalation, issue management, root cause thinking, and corrective action
- Prepare summary reports for management on process risks and improvement priorities
- Support regulatory requirements:
- Ensure CAPA rationales, evidence, and documentation are inspection-defensible
- Participate in governance:
- Contribute to forums with escalation trend analysis, CAPA progress updates, and recommendations
- Other duties: Execute additional tasks as assigned
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Qualifications
Education (Minimum)
Bachelor’s degree preferred in Life Sciences, Quality, Regulatory Affairs, or related discipline. Equivalent work experience may substitute.
Experience (Minimum)
- 8+ years in regulated clinical research, GxP, quality assurance, regulatory compliance, process governance, or related fields
- Demonstrable expertise in:
- Quality systems and CAPA management
- Root cause analysis and escalation handling
- Process improvement in compliance-driven environments
- Proficiency in:
- Understanding GxP regulations and inspection standards
- Analysing quality data/personal trends to identify systemic weaknesses
- Developing clear, risk-based recommendations for cross-functional alignment
- Experience preparing governance updates, quality summaries, and risk communications preferred.
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