Sr. Manager - Quality - Visual Inspection & Particulate Control

Baxter•Round Lake, IL

About The Position

The Sr. Manager - Quality - Visual Inspection & Particulate Control provides strategic and technical Quality leadership for manufacturing and laboratory quality systems, focusing on visual inspection and particulate matter control for injectable products. The role ensures inspection programs, qualification and validation, particulate investigations, and associated controls are scientifically sound, risk-based, well documented, and aligned with regulatory requirements, compendial expectations, and Baxter’s Quality Management System. The position works across Operations, Engineering, Laboratory, and Quality teams to protect patient safety, reduce product quality risks, improve manufacturing controls, and enhance inspection performance. It also supports regulatory inspections, customer audits, and health authority interactions. Baxter describes its mission as saving and sustaining lives and emphasizes a culture of courage, trust, collaboration, accountability, and meaningful impact. The position is open to applicants authorized to work for any U.S. employer; visa sponsorship is not available. The estimated base salary is $136,000–$187,000 annually, and the position may also be eligible for discretionary bonuses. Eligible U.S. benefits include medical and dental coverage beginning on day one; basic life, accident, short- and long-term disability, and business travel accident insurance; an Employee Stock Purchase Plan; a 401(k) plan with company matching; flexible spending accounts; educational assistance; paid holidays; 20–35 days of paid time off based on length of service; family and medical leaves; paid parental leave; commuting benefits; employee discounts; an Employee Assistance Program; and childcare benefits.

Requirements

Bachelor’s degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering, Pharmaceutical Sciences, or a related scientific or technical discipline.
Typically 10+ years of progressive experience in 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 <790> and USP <1790>.
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 functions while maintaining independent quality judgment.
Leadership experience through direct people leadership, matrix leadership, or technical leadership roles.
Must be authorized to work for any employer in the U.S.; Baxter is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

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.

Responsibilities

Lead Quality oversight for manual, semi-automated, and automated visual inspection programs, ensuring processes remain effective, compliant, and aligned with patient safety expectations.
Develop and maintain risk-based particulate control strategies to 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; drive 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 identify emerging issues proactively and ensure sustainable improvements.

Benefits

Medical and dental coverage starting on day one for eligible roles.
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays.
Paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program (EAP).
Childcare benefits.
The position may also be eligible for discretionary bonuses.