New · posted Nov 10
Baxter · Pharmaceuticals
Sr. Manager - Quality - Visual Inspection & Particulate Control
- Round Lake, IL
- On-site
- Full-time
- Manager
The role
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.
What you need
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 Qualificationsnice to have
- 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. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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.
What you'll do
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.
- 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.
Pay
$136,000 – $187,000 a year
Employer providedThis is where your well-being matters. 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
Where you'll work
Round Lake, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in Round Lake, ILEqual opportunity, accessibility and legal noticesBaxter's statements, word for word
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.
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
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $136,000 | — | $187,000 |
This role: Baxter's own published range.
Career trajectory
Where this role sits in Quality Inspection
The general path across 102 open Quality Inspection roles on Regulatory Jobs, with the titles they carry most. Not Baxter's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Collaboration and leadership9
- Quality systems and risk6
- Lab testing and methods5
- Validation and qualification4
- Documentation and SOPs3
- Investigations and CAPA3
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Inspection work in pharmaceuticals, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validationNamed in the posting
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)Named in the posting
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
Company hiring pulse
Baxter on Regulatory Jobs
- 55
- Open roles
- 55
- Distinct roles
- 12
- Locations
By discipline
- Quality51 91%
- Regulatory5 9%
By level
- Associate & Specialist25 45%
- Senior & Principal14 25%
- Manager9 16%
More roles at Baxter
- View role
Inspector, Quality (7pm-7am)
Marion, NCAssociate & SpecialistMedical Devices$40K–$55K
- View role
Inspector, Quality (7pm-7am)
Marion, NCAssociate & SpecialistMedical Devices$40K–$55K
- View role
Quality Inspector (2nd shift)
Skaneateles, NYAssociate & SpecialistMedical Devices$45K–$62K
- View role
Quality Lab Supervisor
Round Lake, ILManagerPharmaceuticals$80K–$110K
Sr. Manager - Quality - Visual Inspection & Particulate Control at Baxter
Open until filled. $136K–$187K a year, employer provided.