GMP Quality Excellence Manager

Role Specific Responsibilities

• Lead the GMP Quality Excellence strategy to deliver reductions in cost of poor quality (COPQ), improvements in yield and right-first-time batch performance, and increased productivity through process standardization and waste elimination.
• Establish and own value-linked KPIs, including COPQ reduction (% and absolute), right-first-time batch performance, batch release cycle time, customer complaint and deviation trends.
• Identify and eliminate non-value-added activities within quality processes to improve efficiency and throughput.
• Lead cross-site continuous improvement initiatives using Lean, Six Sigma, and root cause methodologic approaches.
• Drive the effectiveness and efficiency of the Quality Management System (QMS) to support both compliance and operational performance.
• Standardize quality processes, controls, and documentation across GMP sites to enable scalable and repeatable performance.
• Ensure consistent application of GMP regulations while minimizing operational friction.
• Conduct gap analyses and implement corrective actions to address compliance and performance gaps.
• Lead and embed robust Corrective Action and Preventive Action (CAPA) systems, ensuring sustainable resolution of systemic issues.
• Drive the adoption of digital quality solutions to enhance productivity, data visibility, and compliance.
• Develop and implement data dashboards and reporting frameworks to provide real-time visibility of quality and performance metrics.
• Leverage statistical and predictive analytics (e.g., SPC) to proactively identify risks and improvement opportunities.
• Partner with commercial, supply chain, and operations teams to ensure quality performance supports customer retention, growth, and On-Time In-Full (OTIF) delivery.
• Reduce customer complaints and quality-related disruptions that impact revenue and reputation.
• Embed customer-centric quality practices into site operations.
• Auditing and Inspection Readiness (Risk Mitigation): Ensure GMP sites maintain a state of continuous audit readiness, reducing regulatory and operational risk.
• Analyze audit findings and drive actions to strengthen compliance and prevent recurrence.
• Mitigate risks that could impact site operations, product supply, or regulatory standing.
• Capability Building and Culture: Build quality capability across GMP sites through structured training, coaching, and leadership development.
• Foster a culture of accountability, continuous improvement, and operational excellence.
• Collaboration and Communication: Collaborate across sites and functions to drive enterprise-wide alignment and knowledge sharing.
• Partner with Operations, Engineering, Supply Chain, and Commercial teams to integrate quality into business decision-making.
• Influence senior stakeholders to drive balanced outcomes across compliance, cost, and performance.

Education and Qualifications

• BS degree in Chemistry or Engineering with a MS preferred.
• Strong knowledge of ISO 9001 and CGMP regulations (e.g., 21 CFR Parts 210 and 211).
• ASQ certification (CQE, CQA or CMQ/OE) preferred.
• Knowledge of internal auditing required.
• Leverage Lean and/or Six Sigma certification preferred.