GMP Quality Excellence Manager

Role Specific Responsibilities

• Lead and execute the GMP Quality Excellence strategy to deliver:
  • Reduction in cost of poor quality (scrap, rework, deviations)
  • Improvements in yield and right-first-time batch performance
  • 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 (impacting working capital)
  • 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
• Digital Enablement and Data-Driven Quality: 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 CAPA systems, ensuring sustainable resolution of systemic issues
• Customer and Commercial Alignment: 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
• Auditing and Inspection Readiness (Risk Mitigation): Partner with commercial, supply chain, and operations teams to ensure quality performance supports customer retention, growth, and OTIF delivery
• Reduce customer complaints and quality-related disruptions that impact revenue and reputation
• Embed customer-centric quality practices into site operations
• Capability Building and Culture: Ensure GMP sites maintain a state of continuous audit readiness, reducing regulatory and operational risk
• Build quality capability across GMP sites through structured training, coaching, and leadership development
• Develop site-level quality leadership to enable sustainable, self-sufficient performance improvement
• 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
• Leden and/or Six Sigma certification preferred

Experience

• Minimum of 7 years of QA/QC experience in a CGMP environment (Food, API, Excipient or Pharmaceutical manufacturing)
• Experience leading multi-site or regional/global quality initiatives
• Proven track record of delivering measurable improvements in quality, cost, or productivity
• Experience in data-driven decision-making and statistical process control
• Demonstrated leadership in continuous improvement and transformation initiatives