Sr. Manager - Quality - Visual Inspection & Particulate Control

Baxter; Round Lake Beach (IL); On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

ESPP

401(k) plan

Paid time off

Job summary

Baxter in the United States is seeking a Sr. Manager - Quality to lead Visual Inspection and particulate control for injectable products. You will guide inspection programs, risk-based strategies, and validation activities to ensure compliance with cGMP and regulatory expectations.

This role requires leadership across Operations, Engineering, Laboratory, and Quality, driving investigations, corrective actions, and continuous improvement to safeguard patient safety and product quality.

Qualifications

• Bachelor's degree in a related scientific or technical discipline.
• 10+ years of progressive experience in regulated manufacturing with quality leadership.
• Expertise in visual inspection for injectable/sterile products.
• Experience leading investigations, CAPA, validation, and regulatory responses.
• Strong knowledge of cGMP and USP <790> and USP <1790>.
• Ability to make science-based quality decisions and influence across functions.
• Proven leadership, either people, matrix, or technical.

Responsibilities

• Lead Quality oversight for visual inspection programs across manual, semi-automated, and automated methods.
• Develop risk-based particulate control strategies to reduce product quality risks.
• Provide technical leadership for qualification and validation activities for inspection systems.
• Direct complex investigations involving visible particulates and inspection trends.
• Collaborate with Operations, Engineering, Laboratory, and Quality teams for improvements.
• Support regulatory inspections, audits, and health authority responses.
• Establish and monitor quality metrics, trends, and risk indicators.

Skills

Visual inspection

Quality leadership

CAPA investigations

Regulatory compliance

Cross-functional

Data-driven decisions

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering, Pharmaceutical Sciences, or related

Advanced degree in Pharmaceutical Sciences or related

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

Your Role

The Sr. Manager - Quality - Visual Inspection & Particulate Control provides strategic and technical Quality leadership for manufacturing and laboratory quality systems, with a focus on Visual Inspection and particulate matter control for injectable products. This role ensures that inspection programs, qualification/validation, particulate investigations, and associated controls are scientifically sound, risk-based, well documented, and aligned with regulatory requirements, compendial expectations, and the company Quality Management System.

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 <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 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.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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