Senior Microbiology Quality Leader

Baxter International Inc.; Marion (NC); On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO

Job summary

Baxter International Inc. in the United States is seeking a Senior Quality Manager to lead a team responsible for microbiology testing and quality assurance across raw materials and finished products.

This role focuses on ensuring GMP/GLP compliance, driving continuous improvement, and guiding cross-functional collaboration to meet regulatory requirements. The position requires extensive leadership experience in a cGMP environment, familiarity with USP/FDA/ISO standards, and a commitment to

Qualifications

• Bachelor's degree in Science, biology or microbiology preferred.
• Minimum 10 years in Quality, Manufacturing, Engineering or related field.
• Minimum 7 years in a cGMP-related industry.
• Minimum 5 years of leadership/supervision in aseptic/sterile manufacturing sites.
• Knowledge of microbiology testing techniques and regulatory standards (USP, FDA, ISO).

Responsibilities

• Develop a team of supervisors and department leads for microbiology testing of materials and products.
• Supervise bioburden, endotoxin, and particulate matter testing procedures.
• Ensure GMP/GLP compliance and other relevant standards.
• Coordinate with cross-functional teams on testing requirements and change controls.
• Collaborate with QA to resolve deviations, investigations, and CAPAs.

Skills

Leadership

Communication

Interpersonal skills

Analytical thinking

Problem solving

Education

Bachelor's degree in Science (Biology or Microbiology)

Job description

Baxter International Inc. in the United States is seeking a Senior Quality Manager to lead a team responsible for microbiology testing and quality assurance across raw materials and finished products.

This role focuses on ensuring GMP/GLP compliance, driving continuous improvement, and guiding cross-functional collaboration to meet regulatory requirements. The position requires extensive leadership experience in a cGMP environment, familiarity with USP/FDA/ISO standards, and a commitment to