Manager, Quality

About 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.

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.
• Affords assessment of 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.
• Maintains appropriate quality metrics for trend analysis and Management Review.
• Manages documentation and data requests from Pharma clients, division, and product development and support functions related to QM Manufacturing Quality Assurance and batch release.
• Manages the control and storage of released printed materials and retention samples.
• Communicates at all Plant and Divisional levels.
• Aids 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.
• 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.
• Reviews and approves batch documentation.
• Reviews and approves systems documentation.

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.

Qualifications

• Must be authorized to work for an employer in the U.S.

Skills

• 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.

Benefits

• Medical and dental coverage that starts on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• The Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• The 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.
• Additional benefits including commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.