Manager, Quality

Baxter International Inc.•Round Lake, IL

15d•$112,000 - $154,000•Onsite

About The Position

The Quality Manager serves as the accountable quality leader for dedicated manufacturing operations at the Round Lake Drug Delivery site. This role is responsible for ensuring compliant execution of manufacturing activities through direct QA oversight, robust quality system execution, and effective people leadership. The manager oversees day‑to‑day quality performance within the penicillin area, including batch disposition, deviation and CAPA execution, and strict adherence to contamination control and segregation requirements. The role partners closely with Manufacturing, Engineering, Microbiology, Supply Chain, and other stakeholders to ensure safe, compliant, and reliable product supply.

Requirements

Must not be allergic to Penicillin or Cephalosporin drugs.
Bachelor’s degree in Science, Engineering, or a related discipline required.
Minimum of 3 years of experience in Quality or a related field, with prior experience in pharmaceutical or medical device environment preferred.
Minimum of 1 year of people leadership or supervisory experience required.
Demonstrated knowledge of cGMP regulations (FDA, EU, PIC/S) and quality systems.
Experience with batch record review, deviations, investigations, and CAPA management.
Strong understanding of contamination control and manufacturing compliance principles.
Experience supporting penicillin, sterile, injectable, or highly potent manufacturing operations.
Strong analytical, problem‑solving, and risk‑assessment skills.
Effective communication and collaboration skills across cross‑functional teams.
Ability to manage multiple priorities and lead initiatives in a fast‑paced manufacturing environment.
Ability to work with minimal supervision.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Responsibilities

Interacts with manufacturing and supervision on a daily basis to address quality process or batch related concerns.
Performs process compliance audits of all manufacturing areas to ensure quality of product/process is achieved.
Develops, assigns, and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures. Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance related to CA/PA.
Applies problem solving logically and in an organized manner. Must have experience with Root Cause Analysis tools and the ability to apply tools to plant scenarios.
Manages a team of individuals to drive correction, prevention, and improvement throughout the plant. Is responsible for results in terms of timeliness and conformance to regulations and Baxter quality policies.
Manages documentation and data requests from Pharma clients, division, and product development and support functions related to QM Manufacturing Quality Assurance and batch release.
Maintains appropriate quality metrics for trend analysis and Management Review.
Must have good working knowledge of plant systems, processes, procedures, documentation, and products.
Plays an active role on quality management teams within the organization.
Manage activities of self and Technicians in achieving defined safety, quality, and production goals.
Manages the control and storage of released printed materials and retention samples.
Should be able to communicate at all Plant and Divisional levels.
Assist in external and internal audits by collecting relevant information such as SOP’s and routers.
Drives efforts to identify and implement process efficiencies in order to achieve established release goals.
Seeks new ways to improve and streamline current business and system processes.
Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.
Performs process compliance audits for areas of responsibility.
Review and approve batch documentation.
Review and approve systems documentation.

Benefits

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Medical and dental coverage that start on day one
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
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
the Employee Discount Program
the Employee Assistance Program (EAP)
childcare benefits