Sr. Manager - Quality - Visual Inspection & Particulate Control

What You'll Be Doing

• Lead Quality oversight for manual, semi-automated, and automated visual inspection programs, ensuring inspection processes remain effective, compliant, and aligned with patient safety expectations.
• Develop and maintain risk-based particulate control strategies that strengthen defect prevention, improve manufacturing controls, and reduce product quality risks.
• Provide technical leadership for qualification and validation activities related to visual inspection systems, ensuring studies are scientifically sound, appropriately designed, and fully documented.
• Direct complex investigations involving visible particulate matter, inspection trends, and product quality events, driving objective root cause analysis and effective corrective actions.
• Partner with Operations, Engineering, Laboratory, and Quality teams to identify opportunities for process improvement, defect reduction, and continuous enhancement of inspection performance.
• Support regulatory inspections, customer audits, and health authority interactions by providing expertise, documentation, and responses related to visual inspection and particulate control programs.
• Establish and monitor quality performance metrics, trend analyses, and risk indicators to proactively identify emerging issues and ensure sustainable improvements.

What You'll Bring

Required Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering, Pharmaceutical Sciences, or a related scientific or technical discipline.
• Typically 10+ years of progressive experience within pharmaceutical, biopharmaceutical, medical device, or other highly regulated manufacturing environments, including significant Quality leadership responsibilities.
• Demonstrated expertise in visual inspection programs for injectable or sterile products, including inspection strategy, defect classification, qualification programs, and performance monitoring.
• Experience leading complex investigations, risk assessments, corrective and preventive action (CAPA) programs, validation activities, and regulatory inspection responses.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and applicable compendial requirements, including USP and USP .
• Experience making science-based quality decisions involving product disposition, compliance risk management, and quality system effectiveness.
• Strong communication, collaboration, and influencing skills with the ability to build alignment across multiple functions while maintaining independent quality judgment.
• Leadership experience through direct people leadership, matrix leadership, or technical leadership roles.

Preferred Qualifications

• Advanced degree in Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, or a related discipline.
• Experience supporting commercial sterile manufacturing operations for injectable pharmaceutical products.
• Expertise in particulate characterization techniques, defect identification, and contamination control strategies.
• Experience implementing continuous improvement initiatives that improve inspection effectiveness, defect prevention, and process capability.
• Experience interacting directly with the FDA, Health Canada, EMA, or other global regulatory agencies.
• Certification or advanced training in Quality Risk Management, Lean Six Sigma, or related continuous improvement methodologies.