品質專案(資深)經理 Quality Project (Sr.) Manager

Position Summary:

The Quality PMO Lead is responsible for planning, coordinating, and organizing work across the full lifecycle of pharmaceutical quality portfolios, compliance remediation programs, and operational transformations. The role establishes the structural framework needed to translate quality targets, compliance mandates, and data integrity standards into coordinated, traceable execution across R&D, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, and Manufacturing Operations.

Key Responsibilities:

1. PMO Governance, Portfolio Visibility & Standardization

• Establish and manage the Quality PMO to provide a single source of portfolio visibility and standardize project management methodologies tailored to regulated environments.

• Define decision rights for governance escalation, change controls, Corrective and Preventive Actions (CAPAs), and risk acceptance across site-level and global quality initiatives.

2. Program Execution & Cross-Functional Coordination

• Lead high-visibility, cross-functional programs, including cGMP compliance remediation, digital quality transformations, laboratory facility expansion, new product method transfers, and continuous quality improvement initiatives.

• Coordinate workstreams across departments with independent priorities, bridging gaps between technical quality functions and shop-floor manufacturing operations.

• Establish live dashboards for QA and QC operations to enable real-time monitoring of daily quality activities, performance, and key priorities.

3. Risk Management & Audit Readiness

• Coordinate audit and inspection preparation activities, organize cross-functional team (CFT) meetings, and track the closure of audit findings and associated remediation actions.

• Establish proactive mitigation strategies and escalation triggers for high-impact quality risks before they develop into critical compliance issues.

4. Resource, Budget & Performance Reporting

• Collaborate with functional line managers and Finance teams to assess resource constraints, quality capacity bottlenecks, and project budget variances.

• Deliver transparent, executive-level dashboard reports detailing Key Quality Performance Indicators (KPIs) and milestone achievements to senior leadership.