Sr. Manager - Quality - Visual Inspection & Particulate Control

Zvh; United States; On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) Retirement Savings Plan (RSP)

Paid time off and holidays

Job summary

Baxter is seeking a Sr. Manager - Quality for Visual Inspection & Particulate Control. You will lead quality oversight across inspection programs, drive risk-based particulate strategies, and supervise qualification/validation activities to ensure regulatory compliance and patient safety.

You will partner with Operations, Engineering, and Quality to drive continuous improvement, support audits, and monitor quality metrics for sustainable improvements.

Qualifications

• Bachelor's degree in a relevant scientific or technical discipline.
• Typically 10+ years of progressive experience in regulated manufacturing with quality leadership.
• Expertise in visual inspection programs for injectable products.
• Experience leading investigations, CAPA programs, validation activities, and regulatory responses.
• Strong knowledge of cGMP and compendial requirements (USP <790> and USP <1790>).
• Strong communication and collaboration across functions.

Responsibilities

• Provide strategic and technical Quality leadership for visual inspection and particulate control.
• Lead manual, semi-automated, and automated inspection programs for compliance and patient safety.
• Develop risk-based particulate control strategies to reduce quality risk.
• Oversee qualification and validation for visual inspection systems.
• Direct investigations into visible particulates and quality events with root-cause analysis.
• Collaborate with Operations, Engineering, Laboratory, and Quality to improve processes.
• Support regulatory inspections and customer audits with documentation and responses.

Skills

Quality leadership

Visual inspection

Particulate control

Regulatory inspections

CAPA investigations

cGMP knowledge

Cross-functional collaboration

Education

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

Advanced degree in Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, or related discipline

Job description

This is where your 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.

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.

Compensation

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)

• Medical and dental coverage that starts on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• Flexible Spending Accounts and educational assistance programs.
• 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.
• Commuting benefits, employee discount program, employee assistance program (EAP), and childcare benefits.

Join us and enjoy the competitive compensation and benefits we offer to our employees.

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.

Accommodation

We are 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, let us know the nature of your request along with your contact information.

This is where you belong.